AUGUST 2007
WEEK ENDING AUGUST 4
PRODUCT
a)
ShiR Fresh Anticavity Fluoride Toothpaste, Mint Flavor, Net Weight 9 oz.,
labeled ingredients include: Sodium Monofluorophosphate
0.70%, Glycerin, Sorbitol. Made in China,
b) ShiR Fresh Anticavity Fluoride Toothpaste, Ice ShiR Mint
Flavor, Net Weight 6.4 oz., labeled ingredients include:
Sodium Monofluorophosphate 0.70%, Glycerin, Sorbitol. Made in China,
c) ShiR Fresh
Anticavity Fluoride Toothpaste, Cool ShiR Mint flavor, Kids Mint, Net Weight 6.4 oz., labeled ingredients include: Sodium
Monofluorophosphate 0.70%, Glycerin, Sorbitol. Made in
China,
CODE
a) Lots:
777A, 777B, 777C, 777D;
b) Lot: 2471A;
c) Lot: 2471B
RECALLING
FIRM/MANUFACTURER Gold City Enterprise, LLC, Aventura, FL
REASON Toothpaste from China contains the poisonous
chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN
COMMERCE 155,880
tubes
DISTRIBUTION FL
PRODUCT OXYCODONE
and ASPIRIN Tablets USP 4.5 mg -0.38 mg ** -325 mg Tablet 100 tablets RX only,
CODE
Batch# M920110 Lot# L6E0600A Exp
Date 9/07; Batch# M947980 Lot# L6E0602B Exp Date 12/07; Batch# M975710 Lot#
L6G0851A Exp Date 3/08 and Batch# 992490 Lot# L6K1209A Exp Date
4/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal
Health, Zanesville, OH,
Manufacturer:
Watson Laboratories Inc., Corona, CA.
REASON Product may not meet aspirin dissolution
specifications through the labeled expiration dates.
VOLUME OF
PRODUCT IN COMMERCE 4,700
tablets
DISTRIBUTION CA and MA
PRODUCT Little
Teethers by Little Remedies, Homeopathic Teething Tablets, 150 count bottles,
OTC, Active Ingredients: Belladona 3x HPUS (0.0003% alkaloids), Calcarea
Phosphorica 3x HPUS, Chamomilla 3x HPUS, Coffea Cruda 3x HPUS. --- NOTE: this
product is homeopathic and is to be taken orally, specifically sublingual or
dissolved in a teaspoon of water for administration orally, UPC 7-56184-12090-3,
CODE
Lots 14789, 14908, 14933, 14966,
15010, 15028
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Medtech Products, Inc., Irvington, NY
Manufacturer: Washington Homeopathic Products, Inc., Berkeley
Springs, WV.
REASON Failed Dissolution; product failed to
dissolve instantly as labeled
VOLUME OF PRODUCT IN
COMMERCE 1,205 cases (36 – 150 tablet bottles per
case)
DISTRIBUTION Nationwide
PRODUCT
a)
fougera Mupirocin Ointment USP, 2%, Net. Wt. 22 grams tubes (NDC
0168-0352-22);
b) Foilpacs (NDC 0168-0352-09), Net Wt. 72 x 0.9 g (1/32 Oz),
Rx only, CODE
a) Lots: T416 (exp.
8/07), X579 (exp. 7/08), X580 (exp. 11/08), U221(exp. 12/07), U323 (exp. 12/07);
b) Lots: T298 (exp. 8/07), T299
(exp. 8/07), U010 (exp. 11/07), U011 (exp. 11/07), U239
(exp. 12/07), U345 (exp. 1/08)
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Altana Inc., Melville, NY
Manufacturer: Altana Inc., Hicksville NY.
REASON
The product is subpotent.
VOLUME OF PRODUCT IN COMMERCE 9 g foil packs:
59,832 units; 22 g tubes: 173,805
units
DISTRIBUTION Nationwide, PR, and Bermuda
PRODUCT Metadate®
ER Tablets (methylphenidate hydrochloride extended-release tablets, USP), 10 mg,
100 Tablets, Rx only, NDC 53014-593-07. --- Please note: There was a labeling
change between the packaging of lot 40641 and 41837, so there are 2 labels: one
lists Celltech Pharmaceuticals, Inc., (now known as UCB Manufacturing, Inc.);
the other lists UCB,
CODE Lots 41837
(expiration date 09/08) and 40641 (expiration date 09/08)
RECALLING
FIRM/MANUFACTURER UCB Manufacturing, Inc., Rochester, NY
REASON
Failure to meet dissolution
specification.
VOLUME OF PRODUCT IN COMMERCE 1,531 – 100
count bottles
DISTRIBUTION MA, NJ, NY, PA, VA, NC, TN,
KY, OH, MN, ND, IL, MO, CA, HI, WA, Puerto Rico, and St.
Thomas
PRODUCT Nystatin
Oral Suspension, USP, 100,000 units per mL, Rx only, 1 pint (473mL) and 60mL
bottles, NDC 0603-1453-47,
CODE Lot
Numbers: L094B07A, L094B07B, L113B07A
RECALLING
FIRM/MANUFACTURER Vintage Pharmaceuticals LLC, Huntsville, AL,
REASON
Failed Content Uniformity
Requirements.
VOLUME OF PRODUCT IN COMMERCE 41,117
units
DISTRIBUTION Nationwide
WEEK ENDING AUGUST 11
PRODUCT
INVANZ
Injection, (Ertapenem Sodium) IV/IM, I g single dose vial, pack of 10 vials,
shipped in cases that contain 24 packages of 10 vials, NDC number 0006-3843-71
CODE
Lot number 0803930 exp 10/2008,
Lot number 0803940 exp 10/2008, and Lot number 0803950 exp
10/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Merck
& Co., Inc., West Point, PA
Manufacturer:
Laboratories Merck Sharp & Dohme, Clermont-Ferrand Cedex, France.
REASON
Presence of Foreign
Substance; glass pieces.
VOLUME OF PRODUCT IN
COMMERCE 76,100
vials
DISTRIBUTION Nationwide
PRODUCT DentalPro
Fresh Spearmint Flavor Fluoride Toothpaste and Toothpaste with Brush Combo, 6.4
oz. tubes, labeled ingredients include Sodium monofluorophosphate 0.8% and
Diglycol,
CODE All
lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: PR
Retail Stores, Inc., Carolina, PR
Manufacturer:
Goldcredit International Enterprises, Wuxi, Jiangsu, China (Mainland).
REASON
Toothpaste from China
contains the poisonous chemical diethylene glycol (DEG).
VOLUME OF
PRODUCT IN COMMERCE 40,608
units
DISTRIBUTION PR
PRODUCT BrightMax
Cool Peppermint Flavor Cavity Fighting Fluoride Toothpaste and Toothpaste/Brush
combo, 1.76 oz and 6.4 oz tubes, labeled ingredients include Sodium
monofluorophosphate 0.8%, Sorbitol and Diglycol
CODE All lots
RECALLING
FIRM/MANUFACTURER
Recalling Firm: PR Retail Stores, Inc.,
Carolina, PR
Manufacturer: Goldcredit
International Enterprises, Wuxi, Jiangsu, China (Mainland).
REASON
Toothpaste from China contains
the poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN
COMMERCE Approx 193,616
units
DISTRIBUTION PR
PRODUCT
a)
Dentakleen Fluoride Toothpaste, multiple flavors including Regular, Fresh Mint
and Winterfresh, 6.4 oz tubes, labeled ingredients
include Sodium Monofluorophosphate 0.7% and Sorbitol,
b) Denta-kleen Junior Fluoride Toothpaste,
Strawberry and Blueberry flavors, Net Weight 50 g tubes,
labeled ingredients include Sodium Monofluorophosphate 500 ppm, Glycerin, and
Sorbitol,
CODE All lots
RECALLING
FIRM/MANUFACTURER
Recalling Firm: PR Retail Stores, Inc.,
Carolina, PR
Manufacturer: Goldcredit
International Enterprises, Wuxi, Jiangsu, China. REASON Toothpaste from China may contain the
poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN
COMMERCE Approx. 7,112
units
DISTRIBUTION PR
PRODUCT
a)
Maxipime (Cefepime Hydrochloride, USP) for Injection, ADD-Vantage vial, Rx only. Sold in the following sizes:
1) 1 gram Cefepime, NDC
51479-054-20;
2) 2 grams Cefepime, NDC 51479-055-10,
b) Maxipime
(Cefepime Hydrochloride, USP) for Injection,
Rx only. Distributed in the following sizes:
1) 1 gram
Cefepime, NDC 51479-054-30;
2) 2 grams Cefepime, NDC
0003-7733-20 and NDC 51479-055-30, CODE
a) 1) Lots: 4M63137, exp. 09/30/07;
5A00172, exp. 09/30/07; 5A00173, exp. 09/30/07;5E06850, exp. 10/31/07;
5J09468, exp. 06/30/08;
2) Lot: 4L74769, exp. 08/31/07;
b) 1) Lots: 4K83265,
exp. 07/31/07; 4K83266, exp. 07/31/07; 5K03507, exp. 06/30/08; 5K03509, exp. 06/30/08; 6D11827, exp. 06/30/08; 5K06842,
exp. 07/31/08; 5K07319, exp. 07/31/08; 5K03511, exp.
06/30/08; 5K08170, exp. 07/31/08; 6A16112, exp. 07/31/08;
2) Lots: 5J06310, exp. 05/31/08; 5J06311, exp. 04/30/08;
5J06312, exp. 05/31/08; 5J08880, exp. 05/31/08; 5J09810,
exp. 06/30/08
RECALLING FIRM/MANUFACTURER
Bristol Myers
Squibb Manufacturing Co., Barceloneta, PR
Distributed by Elan Pharmaceuticals, Inc., San
Diego, CA.
REASON Lack of assurance of
sterility.
VOLUME OF PRODUCT IN COMMERCE 1,081,000
vials
DISTRIBUTION Nationwide and Internationally
WEEK ENDING AUGUST 18
PRODUCT H
S Joy of Love Sexual Energizer 100% Pure Herbal Extract 500mg/Cap, 12 Caps/box,
CODE
''USEBY 09-05-09 LOT #
I-05-06-2''
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Jen-On Herbal Science International Inc., City of Industry, CA,
Manufacturer:
Herbal Science International, Inc.,
Walnut, CA. F
REASON Unapproved New Drug. Product has been found to
contain piperadino vardenafil, an analogue of Vardenafil, an FDA-approved drug
used to treat Erectile Dysfunction (ED).
VOLUME OF PRODUCT IN
COMMERCE 2,484 boxes
DISTRIBUTION CA, CO, FL,
NV, TX, WA, NJ, IL, MA
PRODUCT
a)
Novolog Insulin Aspart Injection (rDNA origin), U-100, 100 units/mL human
insulin, Rx; distributed in the following containers:
a) Novolog, 10 mL vials, NDC 0169-7501-11, Walgreen item 680728
b) Novolog
PenFill, 5 x 3 mL PenFill cartridges for use with NovoPen 3,
insulin delivery devices, NDC 0169-3303-12, Walgreen item
675572 c) Novolog Flexpen Prefilled Syringe, 5 x 3 mL
pre-filled insulin syringes, NDC 0169-6339-10, Walgreen item 680670 "NovoLog in unopened vials, cartridges and NovoLog
Flex-Pen prefilled syringes should be stored
between 2°
and 8°C (36° to 46°F). Do not freeze. Do not use NovoLog if it has been frozen
or exposed to temperatures that exceed 37°C (98.6°F).
b) Novolog Mix 70/30, 70% Insulin Aspart Protamine
Suspension and 30% Insulin Aspart Injection, (rDNA
origin), U-100, 10 mL vial, 100 units/mL human insulin, Rx only, NDC
0169-3685-12, Walgreen item 675106 "NovoLog Mix 70/30
should be stored between 2° and 8°C (36° to 46°F).
Do not
freeze. Do not use NovoLog Mix 70/30 if it has been frozen."
c) Novolin R Regular Human Insulin Injection
(rDNA origin) U-100,
100 units/mL, OTC, 10 mL vials; NDC 0169-1833-11,
Walgreen item 681247 Novolin R should be stored between 2° and 8°C (36° to 46°F). Do not freeze,
d) NPH Human Insulin
(rDNA origin) Isophane Suspension, U-100,
100 units/mL, OTC, distributed under the following labels
and containers: a) Humulin N NPH Human Insulin (rDNA
origin) Isophane Suspension, HI-310, 10 mL vials, NDC 0002-8315-01, Walgreen item 676096; c) Novolin N NPH Human Insulin
Isophane Suspension (rDNA origin), 10 mL vials, NDC
0169-1834-11, Walgreen item 681245; Insulin should be
stored in a cold place, preferably in a
refrigerator, but not in the freezing compartment. Do not let it freeze,
e) 70% Human Insulin
Isophane Suspension 30% Human Insulin Injection (rDNA origin), U-100, 100 units/mL human insulin, OTC, distributed under the
following containers:
a) Humulin 70/30, HI-710, 10 mL
vials, NDC 0002-8715-01, Walgreen item 678064
b) Humulin
70/30 Pen, 5 x 3 mL Disposable Pen Insulin Delivery Devices, HP-8770, NDC 0002-8770-59, Walgreen item
680333
c) Novolin 70/30, 10 mL vials, NDC 0169-1837-11,
Walgreen item 679253
d) Novolin 70/30 InnoLet Insulin
Pen, 5 x 3 mL pre-filled disposable insulin dosers,
NDC 0139-2317-21, Walgreen
item 652443
e) Novolin 70/30 PenFill, 5 x 3 mL cartridges
for use with NovoPen 3 Insulin Delivery Device, NDC 0169-3477-18, Walgreen item
681599 Insulin should be stored in a cold place, preferably
in a refrigerator, but not in the
freezing compartment. Do not let it freeze.
f) Humalog Insulin Lispro Injection
(rDNA origin), U-100, 100 units/mL human insulin, Rx, distributed in the following
containers:
a) Humalog, 10 mL vials, VL-7510, NDC
0002-7510-01, Walgreen item 673093
b) Humalog Pen, 5 x 3
mL Disposable Insulin Delivery Devices, HP-8725, NDC 0002-8725-59, Walgreen item 680332 Humalog
should be stored in a refrigerator between 2° and 8°C (36° to 46°F), but not in the
freezing compartment. Do not let it freeze. Do not use Humalog
if it has been frozen,
g)
Humalog Mix 75/25, 75% Insulin Lispro Protamine Suspension 25% Insulin Lispro
Injection (rDNA origin), U-100, 100 units/mL human
insulin, Rx, distributed in the following containers:
a)
Humalog Mix 75/25, 10 mL vial, VL-7511, NDC 0002-7511-01, Walgreen item 676801
b) Humalog Mix 75/25 Pen, 5 x 3 mL Disposable Insulin
Delivery Devices, HP-8794, NDC
0002-8794-59, Walgreen item 677240 Insulin should be stored in a cold place,
preferably in a refrigerator, but
not in the freezing compartment. Do not let it freeze,
h) Levemir Insulin Detemir Injection,
(rDNA origin), U-100, 3 mL
FlexPen Prefilled Syringe, 5 x 3 mL pre-filled insulin
syringes, 100 units/mL insulin detemir, Rx only, NDC 0169-3439-10, Walgreen item 592360 "Do not refrigerate. Do not freeze,"
i) Lovenox Injection, enoxaparin sodium 100
mg/mL,
an Rx SVP; distributed in the following containers: a) 40
mg/0.4 mL Prefilled Syringe, 10 syringes per box, NDC #0075-0620-40, Walgreen item 686176
b) 60 mg/0.6
mL Graduated Prefilled Syringe, 10 syringes per box, NDC #0075-0621-60, Walgreen item 686174 c) 80 mg/0.8
mL Graduated Prefilled Syringe, 10 syringes per box, NDC #0075-0622-80, Walgreen item
686173 d) 100 mg/1 mL Graduated Prefilled Syringe, 10 syringes per box, NDC #
0075-0623-00, Walgreen item 686175 Store at 25°C (77°F);
excursions permitted to 15-30°C
(59-86°F),
j) Medroxyprogesterone Acetate Injection
Suspension, 150mg/mL, an Rx svp hormone; distributed as
follows:
a) in a 1 mL prefilled glass syringe, NDC #0703-6811-21, Walgreen item
600936
b) in a 1mL vial; NDC #59762-4537-01, Walgreens
item 605717 Store at controlled room temperature 20-25°C
(68-77°F),
k) Progesterone Injection,
50mg/mL, an Rx
svp hormone in 10 mL vial; NDC #00591-3128-79, Walgreen
item 682894 Store at 25°C (77°F); excursions permitted to 15-30°C
(59-86°F),
l) Androderm extended
release transdermal patch, testosterone 5mg/24 hours; an Rx C-III hormone gel; 30 patch pouches per box; NDC #52544-0470-30, Walgreen
item 673155 Store patches
at 25°C (77°F); excursions
permitted to 15-30°C (59-86°F) in their sealed pouches until
use.
m) Climara estradiol
transdermal system, 0.075mg/24 hours, 5.7 mg of estradiol USP per patch, 4 patch pouches per box; NDC #50419-453-04, Walgreen item
674916 Do not store above 86°F (30°C). Do not store unpouched,
n) Climara Pro
(Estradiol/Levonorgestrel
Transdermal System), 0.045 mg/day estradiol and 0.015
mg/day levonorgestrel - each patch contains 4.4 mg of estradiol and 1.39 mg
of levonorgestrel, 4 patch pouches per box; NDC
50419-491-04, Walgreen item 672455 Store at 20-25°C
(68-77°F); excursions permitted to 15-30°C (59-86°F),
o) Lidoderm (lidocaine 5%) Patch; Each adhesive patch contains 700 mg of
lidocaine (50 mg per gram adhesive) in an aqueous base;
an Rx local anesthetic agent; box of 30 patches, packaged
into individual child-resistant envelopes; NDC 63481-687-06, Walgreen item 677264 Store at 25°C (77°F); excursions
permitted to 15°-30°C (59°-86°F),
p) Ortho Evra Transdermal System
(norelgestromin and ethinyl estradiol, 0.15 mg - 0.02 mg/24 hours; each patch
contains 6.00 mg norelgestromin (NGMN) and 0.75 mg ethinyl estradiol (EE); an Rx contraceptive; the patches were sold in folding cartons
of 1 cycle each, with each cycle containing 3 patches,
and 6 cartons per box; NDC # 0062-1920-15, Walgreens item 680711 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Store
patches in their protective pouches. Apply immediately
upon removal from the protective pouch. Do not store in the refrigerator or freezer,
q) Vivelle Dot
Estradiol Transdermal System, 0.05mg/24 hours; each patch contains 0.78 mg
estradiol; an Rx hormone; the patches were sold in
calendar packs containing 8 patches, and 3 calendar packs
per box; NDC #0078-0344-45, Walgreens item 684872 Store at controlled room
temperature 25°C (77°F),
r) EpiPen Auto-Injector, each EpiPen auto-injector delivers a single dose of
0.3 mg epinephrine from epinephrine injection, USP,
1:1000 (0.3 mL) in a sterile solution; an Rx svp; the EpiPens were distributed in the following configurations: a) a
single EpiPen auto-injector in an individual carton, NDC
49502-500-01, Walgreen item 678922 b) EpiPen 2-Pak, a pack that contains two EpiPen auto-injectors and one EpiPen trainer device, NDC
49502-500-02, Walgreen item 675592 Store at 25°C (77°F);
excursions permitted to 15°C-30°C (59°F-86°F),
s)
Glucagon Emergency Kit for Low Blood Sugar (Glucagon for Injection [rDNA
origin]) (MS8031): 1 mg (1 unit)-(VL7529), with 1 mL of
diluting solution and 1 Hyporet * HY7530 disposable
syringe); NDC 0002-8031-01, Walgreen item 676712 Before Reconstitution -- Vials
of Glucagon, as well as the Diluting Solution for Glucagon, may be stored at controlled room temperature 20° to 25°C (68° to 77°F),
t)
ALPHAGAN® P (brimonidine tartrate) ophthalmic solution, brimonidine
tartrate 0.15% (1.5 mg/mL); an Rx sterile ophthalmic
solution; 10 mL in 10 mL dropper bottle; NDC
0023-9177-10, Walgreen item 672813 Store at 15°-25° C (59-77°F),
u)
ALREX® (loteprednol etabonate) ophthalmic
suspension, Loteprednol Etabonate 2 mg (0.2%); an Rx
sterile, topical anti-inflammatory corticosteroid for ophthalmic use; packaged
in a plastic bottle with a controlled drop tip in the
following sizes:
a) 5
mL, AB35307, NDC 24208-353-05,
Walgreen item 673219
b) 10 mL, AB35309, NDC 24208-353-10,
Walgreen item 673220 Store upright between 15°-25°C
(59°-77°F). DO NOT FREEZE, Recall # D-869-2007;
v)
AZOPT® (brinzolamide) ophthalmic suspension
1%, an Rx sterile ophthalmic supplied in 15 mL plastic DROP-TAINER® dispensers with a controlled dispensing-tip; NDC 0065-0275-15, Walgreen item 680158 Store at 4-30°C (39-86°F),
w)
Betimol® (timolol) ophthalmic solution
0.5%, each mL contains 5.12 mg of timolol hemihydrate
equivalent to 5.0 mg timolol; an Rx, sterile non-selective beta-adrenergic
antagonist for ophthalmic use; 10mL fill in 11 cc white,
opaque, plastic, ophthalmic dispenser bottle with a controlled
drop
tip; NDC 68669-525-10, Walgreen item 673885 Store
between 15-30°C (59-86°F). Do not freeze. Protect from
light,
x) Ciprofloxacin Hydrochloride Ophthalmic
Solution 0.3%, packaged in a 5 mL dropper bottle, each mL
Ciprofloxacin HCl 3.5 mg equivalent to 3 mg base; an Rx, sterile fluoroquinolone antibacterial; NDC 61314-0656-05, Walgreen item 670446
Store between 2-25°C (36-77°F). Protect from light,
y) Cosopt
(dorzolamide hydrochloride-timolol
maleate)ophthalmic solution, each mL of COSOPT contains
20 mg dorzolamide (22.26 mg of dorzolamide hydrochloride) and 5 mg timolol (6.83 mg timolol
maleate); an Rx, sterile combination of
a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent; 10 mL in an 18 mL capacity a white, translucent, HDPE plastic ophthalmic dispenser bottle
with a controlled drop tip and a white polystyrene cap;
NDC 0006-3628-36, Walgreen item 674907 Store COSOPT at 15-30°C (59-86°F). Protect from light,
z)
Fluorometholone Ophthalmic Suspension, USP 0.1%, an Rx sterile, topical
anti-inflammatory agent for ophthalmic use; 10 mL dropper
bottle; NDC 60758-0880-10, Walgreen item 599171 Store
between 2° and 25°C (36°-77°F); protect from freezing. Shake well before using,
aa) Flurbiprofen Sodium
Ophthalmic Solution 0.03%; flurbiprofen sodium 0.3 mg/mL; 2.5.mL dropper bottle; NDC 24208-0314-25, Walgreen item
677573 Store at 15°25°C (5977°F),
bb) Gentamicin Sulfate Ophthalmic Solution 0.3%, 3
mg/mL
gentamicin sulfate; an Rx, sterile ophthalmic
antibiotic; 5mL dropper bottle; NDC 24208-0580-60, Walgreen item 677824 Store between 15-25°C (59-77°F). Protect from
light,
cc) Levobunolol hydrochloride ophthalmic
solution 0.5%, USP; an Rx sterile, noncardioselective beta-adrenoceptor blocking agent for ophthalmic
use; 5 mL dropper bottle; NDC 24208-0505-05,
Walgreen item 677245, Protect from light. Store at 15°-25°C (59°-77°F),
dd) Lotemax
(loteprednol etabonate) Ophthalmic Suspension 0.5%,
each mL contains Loteprednol Etabonate 5 mg; an Rx
sterile, topical anti-inflammatory corticosteroid for ophthalmic use; 5 mL plastic bottle with a controlled drop tip; NDC
24208-0299-05, Walgreen item 680164 Store upright
between 15°-25°C (59°- 77°F). DO NOT FREEZE,
ee) LUMIGAN
® (bimatoprost) ophthalmic solution 0.03%, each mL contains bimatoprost 0.3 mg; an Rx, sterile, synthetic prostamide analog with
ocular hypotensive activity; packaged in ophthalmic
dispenser bottles and tips with turquoise polystyrene caps in the following
sizes: 2.5 mL fill in 5 mL container - NDC
0023-9187-03, Walgreen item 676729; 5 mL fill in 10 mL container - NDC 0023-9187-05; Walgreen item 676730
LUMIGAN ® should be stored in the original
container at 2° to 25°C (36° to 77°F),
ff) Neomycin And Polymyxin B Sulfates And Dexamethasone Ophthalmic Suspension; 5 mL dropper bottle, each mL contains Neomycin Sulfate equivalent to Neomycin 3.5 mg, Polymyxin B Sulfate 10,000 units, Dexamethasone 0.1%; NDC 61314-0630-06, Walgreen item 671628 Store at 8°- 27° C ( 46°- 80° F),
gg) Ofloxacin Ophthalmic Solution 0.3%; ofloxacin 3
mg/mL, in 5
mL plastic dropper bottles; an Rx, sterile
fluorinated carboxyquinolone anti-infective for topical ophthalmic use; NDC 24208-0434-05, Walgreen item 603423 Storage:
Store at 15°-25°C (59°-77°F),
hh) Optivar Azelastine Hydrochloride Ophthalmic Solution, 0.05%; an Rx,
sterile, relatively selective H 1 -receptor
antagonist for topical administration to the eyes; 6 mL solution in a translucent 10 mL HDPE container with a LDPE
dropper tip; NDC 0037-7025-60, Walgreen item 680796
Store UPRIGHT between 2° and 25°C (36° and 77°F),
ii)
PATANOL® (olopatadine hydrochloride) ophthalmic
solution 0.1%; an Rx, sterile, relatively selective
H 1 - receptor antagonist and inhibitor of histamine release from the mast cell for topical administration to the eyes; each
mL contains 1.11 mg olopatadine hydrochloride
equivalent to 1 mg olopatadine, 5 mL in plastic DROP-TAINER® dispenser; NDC
0065-0271-05, Walgreen item 681863 Store at
39°F-77°F (4°C-25°C),
jj) Polmyxin B Sulfate And
Trimethoprim Ophthalmic Solution, USP; polymyxin B sulfate 10,000 units/mL; trimethoprim sulfate equivalent to 1
mg/mL; an
Rx, sterile antimicrobial solution for topical ophthalmic
use; 10 mL dropper bottle; NDC 61314-0628-10, Walgreen item 684677 Store
at 15°-25°C (59°-77°F) and protect from light,
kk) Prednisolone Acetate Ophthalmic Suspension 1%; an Rx,
sterile, topical anti-inflammatory agent for
ophthalmic use; packaged in 5 mL and 10 mL dropper bottles; 5 mL bottle: NDC 61314-0637-05, Walgreen item 682441; 10 mL
bottle: NDC 61314-0637-10, Walgreen item 682442;
Store at 15°C-30°C (59°F-86°F). Protect from freezing. Store in an upright
position,
ll) RESTASIS® (cyclosporine) ophthalmic emulsion 0.05%; an Rx, sterile topical immunomodulator with anti-inflammatory effects; Each single use vial
contains 0.4 mL fill in a 0.9 mL LDPE vial/32
vials/polypropylene tray with an aluminum peelable lid; RESTASIS® 32 Vials 0.4
mL each – NDC 0023-9163-32, Walgreen item 675052 Store RESTASIS® ophthalmic emulsion at 15° to 25° C (59°-77° F),
mm) Sulfacetamide Sodium Ophthalmic Solution USP 10%;
sulfacetamide sodium 100 mg/mL; an Rx, sterile, topical
antibacterial agent for ophthalmic use; 15 mL dropper bottle; NDC 24208-0670-04, Walgreen item 683917 Store at 8°-25°C
(46°-77°F). Protect from light,
nn) Sulfacetamide Sodium and Prednisolone Sodium Phosphate
Ophthalmic Solution; sulfacetamide sodium 10%,
prednisolone sodium phosphate 0.23% Eq; an Rx, sterile antibacterial and corticosteroid combination, 10 mL dropper bottle; NDC
61314-0297-10, Walgreen item 671478
Store at room
temperature, between 59 and 77 degrees F (15 and 25 degrees C). Do not freeze. Store away from heat and light,
oo) Timolol maleate ophthalmic gel forming solution 0.25%; each
mL contains 2.5 mg of timolol (3.4 mg of timolol maleate); an Rx, sterile non-selective
beta-adrenergic receptor blocking agent; 5 mL dropper bottle; NDC 61314-0224-05, Walgreen
item 685018 Store at 15-30°C (59-86°F). Avoid
Freezing. Protect from light,
pp)
Timolol maleate
ophthalmic gel forming solution 0.5%; each mL contains 5 mg of timolol (6.8 mg of timolol
maleate); an Rx, sterile
non-selective beta-adrenergic receptor blocking agent; 5 mL dropper bottle; NDC 61314-0225-05, Walgreen
item 685020 Store at 15-30°C (59-86°F).
Avoid
Freezing. Protect from light,
qq) Timolol maleate
ophthalmic solution 0.5%; each mL contains 5 mg of timolol (6.8 mg of timolol
maleate); an Rx, sterile non-selective beta-adrenergic receptor blocking agent; 5 mL dropper
bottle; gel forming solution: NDC 61314-0227-05, Walgreen
item 685020 solution: NDC 61314-0227-05, Walgreen
item 684681 Store at room temperature, 15-30°C (59-86°F). Protect from freezing. Protect from light,
rr)
Tobradex® (tobramycin and dexamethasone) ophthalmic suspension; each mL contains
Tobramycin 0.3% (3 mg) and Dexamethasone 0.1% (1
mg); an Rx, sterile, multiple dose antibiotic and
steroid combination for topical ophthalmic use; supplied in 5 mL and 10 mL DROP-TAINER®
dispenser bottles. 5
mL: NDC
0065-0647-05, Walgreen item 685118 10 mL: NDC 0065-0647-10, Walgreen item 685006 Store at 8° to 27°C (46° to
80°F),
ss) Tobramycin Ophthalmic Solution USP 0.3%;
each mL of contains tobramycin 3 mg; an Rx
sterile topical ophthalmic antibiotic formulation prepared specifically for
topical therapy of external ophthalmic infections;
5 mL dropper bottle; NDC 24208-0290-05, Walgreen item 684922
Store at 8° - 27°C (46° - 80°F),
tt) Travatan Ophthalmic Solution 0.004%, each mL contains 40 mug
travoprost; an Rx, sterile selective FP prostanoid
receptor agonist; 2.5 mL solution in a 4 mL and a 5 mL solution in a 7.5 mL natural polypropylene dispenser bottle with a
natural polypropylene dropper tip; 2.5 mL fill:
NDC
0065-0266-25, Walgreen item 684662 5 mL fill: NDC 0065-0266-34, Walgreen item 670775 Store at 2°-25°C (36°-77°F),
uu) Vigamox
(moxifloxacin HCl) ophthalmic solution 0.5%;
Moxifloxacin 5 mg/mL; an Rx, sterile 8-methoxy
fluoroquinolone anti-infective for topical ophthalmic use; 3 mL in 6 mL dropper bottle; NDC 0065-4013-03, Walgreen item
683058 Store at 2°C-25°C (36°F-77°F),
vv) Voltaren
(diclofenac sodium) Ophthalmic Solution 0.1%;
diclofenac sodium 1 mg/mL, an Rx, sterile,
topical, non-steroidal, anti-inflammatory product for ophthalmic use; 5.0 mL fill is supplied in a 10.0 mL size low density
polyethylene white bottle with a dropper tip; Made
in Canada, NDC 58768-100-05, Walgreen item 685666 Store at 15°C to 25°C (59° to
77°F),
ww) Zymar (gatifloxacin) ophthalmic solution) 0.3%; gatifloxacin 3
mg/mL; an Rx, sterile 8-methoxy fluoroquinolone
anti-infective for topical ophthalmic use; 5 mL in 10 mL white, low density polyethylene bottle with a
controlled dropper tip; NDC 0023-9218-05, Walgreen
item 686171 Store at 15°-25°C (59°-77°F). Protect from freezing,
xx) Bacitracin 0phthalmic Ointment
USP, 500 units/gram; an Rx,
sterile antibiotic used to treat inflammation and
infections of the eye; 3.5g (1/8 Oz) tube; NDC 0168-0026-38, Walgreen item 673187 Store at room temperature between 15°and
30°C (59°and 86°F). Protect from light,
yy) Ciloxan
(ciprofloxacin hydrochloride) Ophthalmic Ointment
0.03%, each gram contains Ciprofloxacin HCl 3.33 mg
equivalent to 3 mg base; an Rx, sterile, multiple dose, antimicrobial for topical ophthalmic use; 3.5 g aluminum tube;
NDC 0065-0654-35, Walgreen item 674898 Store at 2°
- 25°C (36° - 77°F),
zz) Erythromycin Ophthalmic
Ointment USP 0.5%, each gram contains Erythromycin USP 5 mg; an Rx, sterile antibiotic used to treat
inflammation and infections of the eye; 3.5g (1/8 Oz) tube; dNDC 0168-0070-38, Walgreen item 677034 Store at
controlled room temperature 15°-30°C
(59°-86°F).
Avoid excessive heat. Protect from freezing,
aaa)
Antipyrine-Benzocaine Otic Solution; 1.4% benzocaine and 5.4% antipyrine with
dehydrated glycerin; an Rx, sterile
otic analgesic and anesthetic; 15 mL dropper bottle; NDC 00603-7020-73, Walgreen item 672853 Store at 59° to 86°F.
Protect from light and heat,
bbb) Oticaine
(benzocaine)
20% Otic Drops; an Rx, sterile, otic local anesthetic; 15 mL dropper bottle; NDC 00603-7238-73, Walgreen item
681584 Store at 59° to 86°F. Protect from light and heat,
ccc)
Ciprodex (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension;
each mL of CIPRODEX® Otic contains
ciprofloxacin hydrochloride (equivalent to 3 mg ciprofloxacin base) and 1 mg
dexamethasone; an Rx, sterile
antibacterial/anti-inflammatory suspension for otic use; 7.5 mL fill in a dropper bottle; NDC
0065-8533-02, Walgreen item 673614 Store at controlled room temperature, 15°C to 30°C (59°F to
86°F). Avoid freezing. Protect from light,
ddd) Cipro HC Otic Suspension; each mL contains
ciprofloxacin hydrochloride (equivalent to 2
mg ciprofloxacin base) and 1 mg hydrocortisone; an Rx, sterile
antibacterial/anti-inflammatory suspension
for otic use; 10 mL fill in a dropper bottle; NDC 0065-8531-10, Walgreen item
674909 Store at controlled room temperature,
15°C to 30°C (59°F to 86°F). Avoid freezing. Protect from light,
eee) Floxin
(ofloxacin) Otic Solution 0.3%; ofloxacin 3 mg/mL; an Rx, sterile aqueous
anti-infective (anti-bacterial) solution
for otic use; supplied in plastic dropper bottles containing 5 mL and 10 mL; 5
mL: NDC 63395-101-05, Walgreen item
677763 10 mL: NDC 63395-101-10,
Walgreen item
676975 Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). Protect from light,
fff) Neomycin, Polymyxin B, Hydrocortisone Otic Suspension; each
mL contains 5 mg neomycin sulfate equivalent
to 3.5 mg neomycin, 10,000 units polymixin B, 1% hydrocortisone; an Rx, sterile antibiotic and steroid combination for
otic use; 10 mL dropper bottle; NDC
61314-0645-10, Walgreen item 671630 Store at controlled room temperature, 15°C
to
30°C (59°F to 86°F). Avoid freezing,
ggg) Acetaminophen Elixir; each 2.5 mL contains: Acetaminophen 80
mg; an OTC oral analgesic-antipyretic;
4 fl. oz. bottle Silarx Walgreen item 683280 Store between 20-25°C (68-77°F),
hhh)
Acetaminophen & Codeine Phosphate Oral Solution USP; Each 5 mL contains
Acetaminophen 120 mg, Codeine Phosphate 12
mg; an Rx, Schedule C-V narcotic agonist-antagonist analgesic; 16 fl. oz. bottle; NDC 0121-0504-16, Walgreen
item 672713 Keep tightly closed. Store at
controlled room temperature 15°-30°C (59°-86°F). Protect from light,
iii) Belladonna Alkaloids with Phenobarbital Oral Elixir; an Rx
oral antispasmodic, anticholinergic; each 5 mL
contains phenobarbital 16.2 mg, hyoscyamine sulfate 0.1037 mg, atropine sulfate 0.0194 mg, scopolamine hydrobromide 0.0065
mg; 16 fl. oz. bottle; NDC 0603-1030-58,
Walgreen
item 672847 Store at controlled room temperature 20° -25°C (68° -77°F),
jjj) Carafate (sucralfate)
Suspension; 10 mL contains 1 g of sucralfate; an Rx oral medication; 14 fl oz bottles; NDC 58914-170-14, Walgreen item
674257 Store at controlled room temperature 20
-25°C (68 - 77°F),
kkk) Ceron Oral Drops; each 1 mL
contains Chlorpheniramine Maleate 1 mg, Phenylephrine HCl 3.5 mg; an Rx oral liquid pediatric
decongestant/antihistamine; 1 fl oz dropper bottle;
NDC 60258-416-30, Walgreen item 594430 Store at room temperature between 15 - 30
degrees
C (59 - 86 degrees F),
lll) Cheratussin AC Syrup; each 5 mL contains codeine phosphate
10 mg, guaifenesin 100 mg; an Rx Schedule C-V
narcotic antitussive/expectorant; 16 fl. oz. bottle; NDC 0603-1075-58, Walgreen item 674484 Store at controlled room
temperature 15°-30°C (59°-86°F),
mmm) Cheratussin DAC Syrup; each 5 mL contains codeine phosphate
10 mg, guaifenesin 100 mg, pseudoephedrine
hydrochloride 30 mg.; an Rx Schedule C-V narcotic antitussive/expectorant/ decongestant; 16 fl. oz.
bottle; NDC 0603-1078-58, Walgreen item 674485 Store at controlled
room temperature 15°-30°C (59°-86°F),
nnn)
Chlorhexidine Oral Rinse; chorhexidine gluconate 0.12%; an
Rx dental solution; 473 mL bottle; NDC
#0093-0014-16, Walgreen item 674434 Store above freezing (32°F),
ooo) Cyproheptadine Syrup; cyproheptadine hydrochloride 2 mg/5
mL, an Rx oral antihistamine liquid; 16 fl oz
bottle; NDC 00472-755-16, Walgreen item 675217 Store at controlled room temperature 15 -30°C (59 - 86°F),
ppp)
Cytra-K Oral Solution; each 5 mL contains: Potassium Citrate
Monohydrate 1100 mg, Citric Acid Monohydrate 334
mg; an Rx oral systemic alkalinizer; 16 fl. oz. bottle; NDC 60258-003-16, Walgreen item 675278 Store at
room temperature, between 68 and 77 degrees F (20
and 25 degrees C),
qqq) Fluoxetine Oral Solution;
fluoxetine hydrochloride, 20 mg per 5 mL; an Rx psychotropic drug for oral administration; 120 mL bottle; NDC
60432-162-04, Walgreen item 669491 Store at
Controlled Room Temperature, 15° to 30°C (59° to 86°F),
rrr) Furosemide Oral Solution, furosemide
10mg/mL; an Rx oral
diuretic; 60 mL bottle; NDC 60432-613-60, Walgreen
item 677647 Store at controlled room temperature 15°-30°C (59°-86°F),
sss)
Griseofulvin Oral Suspension, griseofulvin 125 mg/5 mL;an Rx oral antibiotic
derived from a species of Penicillium; 120 mL
bottle; NDC 10147-0810-04, Walgreen item 597032 Store at controlled room temperature 15°-30°C (59°-86°F) in
tight, light-resistant containers,
ttt) H-C Tussive Syrup; each 5 mL contains phenylephrine
hydrochloride 5 mg, chlorpheniramine maleate 2 mg,
and hydrocodone bitartrate 2.5 mg; an Rx Schedule C-III narcotic antitussive combination; 16 fl. oz. bottle; NDC 0603-1284-58,
Walgreen item 679787 Store at controlled room
temperature 15°-30°C (59°-86°F);
uuu) Ibuprofen Oral
Suspension, ibuprofen 100mg/5mL; an OTC oral liquid nonsteroidal anti-inflammatory; 16 fl. oz.
bottle; NDC 0472-1270-16, Walgreen item 680154 Store at 20-25°C (68-77°F)
vvv) Keppra Oral Solution; levetiracetam
100mg/mL; an Rx
antiepileptic drug; 16 fl. oz. bottle;
NDC 50474-001-48, Walgreen item 580957 Store at 25°C (77°F); excursions
permitted to 15-30°C (59-86°F),
www) Lidocaine Hydrochloride Oral Topical Solution, USP 2%
(Viscous), each mL contains: lidocaine
HCl 20 mg.; an Rx local anesthetic agent administered topically; 100 mL bottle; NDC 50383-775-04, Walgreen item 684578
Store between 15 and 30°C. Protect from freezing,
xxx) Loratadine
Syrup, Loratadine 5mg/5mL; an OTC oral antihistamine; 120 mL bottle; NDC 51672-2073-8, Walgreen item 659679,
Store between 20° to 25° C (68° to 77° F),
yyy) Nystatin
Oral Suspension USP; nystatin, 100,000 units/mL ; an Rx oral antifungal
antibiotic; 16 fl oz bottle; Qualitest
Products, 130 Vintage NDC 0603-1481-58, Walgreen item 570689, Store in a refrigerator, 2°-8°C
(36°-46°F). Protect from light. Dispense in a tight, light-resistant container,
zzz)
Phenobarbital Elixir; phenobarbital 20mg/5mL; an Rx barbiturate; 16 fl oz
bottle; Walgreen item 681762 Store this
medicine at room temperature, in a tightly-closed container, away from heat and light,
aaaa) Phenyl
Chlor-Tan Pediatric Suspension; phenylephrine
tannate 5 mg, chlorpheniramine tannate 4.5 mg/5 mL;
an Rx oral antihistamine/decongestant; 16 oz bottle; NDC 50383-842-16,
Walgreen item 681699, Store at room temperature away
from sunlight and moisture,
bbbb)
Phenytoin Oral
Suspension; phenytoin 125mg/5mL; an Rx oral anticonvulsant; 8 fl oz bottle; NDC 00472-067-08, Walgreen item 682101 Store at
controlled room temperature 20°-25°C (68°-77°F).
Protect from freezing and light,
cccc) Poly-Vitamin
Drops with Fluoride 0.25mg; Vitamin A/1500 IU, Vitamin D/400 IU, Vitamin E/5 IU, Vitamin C/35mg, Thiamine/.5mg,
Riboflavin/.6mg, Niacin/8mg, Vitamin B6/.4mg,
Vitamin B12/2mcg, Sodium Fluoride/.25mg/1mL; 50 mL dropper bottle; NDC
50383-642-50 Walgreen item 679260 Store at room
temperature between 59 and 86 degrees F (between 15 and 30 degrees C) away from heat and sunlight,
dddd) Potassium Chloride Oral Solution 20%; 40
mEq/15 mL
potassium and chloride; an Rx oral
electrolyte replacement; 16 fl oz bottle; NDC 00121-466-16, Walgreen item
649799,
eeee)
Prednisolone Syrup, prednisolone 5mg/5ml; an Rx oral corticosteroid; 120ml
bottle; NDC 58177-912-03, Walgreen item 684606,
Store at room temperature, away from heat and light,
ffff) Prednisolone Sodium
Phosphate Oral Solution; prednisolone sodium phosphate 15mg/5mL; an Rx oral
corticosteroid; 8 fl oz bottle; NDC
60432-212-08, Walgreen item 662228 Store between 39
and 77 degrees F (4 and 25 degrees C),
gggg)
Promethazine Hydrochloride and Codeine Phosphate Syrup; promethazine
hydrochloride 6.25 mg, codeine phosphate 10 mg/5 mL; an Rx schedule C-V narcotic antihistamine/cough
suppressant; 16 oz bottle; NDC 50383-804-16, Walgreen item 682586 Store at room
temperature between 68 and 77 degrees F (20 and 25
degrees C), in a tightly-closed container, away from heat and light,
hhhh)
Q-Dryl AF Elixir, Diphenhydramine Hydrochloride Elixir, Alcohol Free;
diphenhydramine HCl 12.5 mg/5 mL; an OTC
antihistamine; 480 mL bottle; NDC 00603-823-58, Walgreen item 566339,
iiii) Q-Pap Drops,
Acetaminophen Oral Drops, acetaminophen 80 mg/0.8 mL, an OTC pain reliever; 15mL bottle; NDC 00603-838-73, Walgreen item 683115
Store at room temperature between 59 and 86 degrees
F (between 15 and 30 degrees C) away from moisture and sunlight. Do not freeze,
jjjj) Sulfatrim Suspension
Pediatric, Grape; Sulfamethoxazole 200 mg and trimethoprim 40 mg/5 mL; an Rx antibacterial; 16 fl oz bottle; NDC
0472-1285-16, Walgreen item 683923 Store at room
temperature, away from heat and light,
kkkk) Tannate-12D
S Suspension; phenylephrine tannate 5 mg , pyrilamine tannate 30 mg, carbetapentane tannate 30 mg/5
mL; an Rx oral antitussive; 118 mL bottle; NDC 50383-841-04,
Walgreen item 655334 Store at room temperature between 68 and 77 degrees F (20
to 25 degrees C) in a tightly-closed container, away
from heat and light,
llll) Tussionex Pennkinetic Oral
Suspension, Extended Release; chlorpheniramine polistirex eq 8 mg maleate/5mL, hydrocodone polistirex eq 10mg
bitartrate/5mL; an Rx schedule C-III narcotic
antihistamine/cough suppressant; 473 mL bottle; NDC 53014-548-67, Walgreen item
680846.
Store at room temperature in a
tightly-closed container, away from heat and light,
mmmm) Zyrtec Syrup; cetirizine hydrochloride 1mg/1mL; an
Rx antihistamine; 120 mL; NDC 0069-5530-47,
Walgreen item 686281 Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room
Temperature]; or Store refrigerated, 2-8°C
(36-46°F),
CODE Shipment numbers
874497, 874503, 874542, 875023, 875114, 877282, 875296, all shipped on
2/16/07
RECALLING FIRM/MANUFACTURER
Walgreen Co., Deerfield, IL, REASON Product was subjected
to below freezing temperatures.
VOLUME OF PRODUCT IN
COMMERCE 7,996 units
DISTRIBUTION IL
PRODUCT Diltiazem
Hydrochloride Extended-Release Capsules 240mg, 90 count bottles, Rx Only,
CODE
P050217 Exp Sept
2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biovail
Pharmaceuticals, Mississauga, Canada,
Manufacturer: Biovail Laboratories International SRL, Dorado, PR.
REASON
Failed USP
Dissolution Specifications.
VOLUME OF PRODUCT IN
COMMERCE 15,555
bottles
DISTRIBUTION Nationwide
WEEK ENDING AUGUST 25
PRODUCT Long
Weekend, Natural Libido Enhancer, (Epimedium P.E. 300 mg, Fructus Lycii P. E. 50
mg), A Dietary Supplement, 3 capsules/box, UPC 809515-0542,
CODE
All lots
RECALLING
FIRM/MANUFACTURER Confidence, Inc., Port Washington, NY
REASON
Unapproved new drug; product
was found to contain undeclared tadalafil, the active pharmaceutical ingredient
in an FDA-approved drug used to treat erectile dysfunction.
VOLUME OF
PRODUCT IN COMMERCE Approximately 4,772
capsules
DISTRIBUTION Nationwide, Canada, UK, Russia,
Spain and China
PRODUCT ChlorproMAZINE
Hydrochloride Tablets, USP, 50 mg, 100 and 1000 count bottles, Rx only. NDC
0832-0302-00 and 0832-0302-01, CODE 237011, 238568,
237005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Upsher
Smith Laboratories, Inc., Maple Grove, MN,
Manufacturer: Upsher Smith Laboratories, Inc., Denver, CO.
REASON
Upsher-Smith
Chlorpromazine Hydrochloride 50 mg tablets, USP may contain an illegible or
missing imprint on tablet.
VOLUME OF PRODUCT IN
COMMERCE 6,892
DISTRIBUTION Nationwide
PRODUCT Dextroamphetamine
Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and
Amphetamine Sulfate Tablets, 10 mg, 100 count bottles, Rx only, NDC
63304-909-01,
CODE Lot: CPE694,
Expiration date: 5/2008
RECALLING
FIRM/MANUFACTURER Corepharma LLC, Middlesex, NJ, by letter on June
12, 2007.
REASON GMP
deviation. Failed blend uniformity requirement
VOLUME OF PRODUCT IN
COMMERCE 7,420 bottles of
100
DISTRIBUTION FL