JANUARY 2006
WEEK ENDING JANUARY 7
PRODUCT
Trypan Blue 0.06%
Ophthalmic Solution, packaged one cc syringes, Rx only
CODE Lot numbers: 08182005:43@17; 08012005:63@24;
06282005:91@27; 05252005:36@13 and 05042005:86@17
RECALLING
FIRM/MANUFACTURER Custom-Rx Compounding Pharmacy, Richfield, MN
REASON
Microbial
contamination (Pseudomonas aeruginosa).
VOLUME OF PRODUCT IN
COMMERCE 219
DISTRIBUTION Nationwide
WEEK ENDING JANUARY 14
PRODUCT
a)
Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m Generator, Parent Molybdenum 99 prepared from
Fission Produced Molybdenum 99, Catalog number N8831L (1.0 curie).
b) Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m
Generator, Parent Molybdenum 99 prepared
from Fission Produced
Molybdenum 99, Catalog number N8841L (1.5 curies).
c) Ultra-TechneKow
DTE, UTK-DTE, Technetium Tc 99m Generator, Parent Molybdenum 99 prepared
from Fission Produced Molybdenum
99,
Catalog number N8851L , 2L (2.0 curies).
d) Ultra-TechneKow DTE,
UTK-DTE, Technetium Tc 99m Generator, Parent
Molybdenum 99 prepared
from Fission Produced Molybdenum 99, Catalog number
N8861L, 2L (2.5 curies).
e) Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m Generator,
Parent Molybdenum 99 prepared
from Fission Produced Molybdenum 99, Catalog number N8871L, 2L (3.0 curies).
f)
Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m Generator, Parent Molybdenum 99 prepared from
Fission Produced Molybdenum 99, Catalog number N8881L, 2L (3.5 curies).
g)
Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m Generator, Parent Molybdenum 99 prepared from
Fission Produced Molybdenum 99, Catalog numbers N8891L, 2L and N8891T, 2T (5.0 curies).
h)
Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m Generator, Parent Molybdenum 99 prepared
from Fission Produced Molybdenum 99, Catalog numbers N8901L, 2L, and
N8901T, 2T (6.0 curies),
i) Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m Generator,
Parent Molybdenum 99 prepared
from Fission Produced Molybdenum 99, Catalog numbers N8911L, 2L, and
N8911T, 2T (7.5 curies),
j) Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m Generator,
Parent Molybdenum 99 prepared
from Fission Produced Molybdenum 99, Catalog number N8921D, 2D (11.0
curie).
k) Ultra-TechneKow DTE, UTK-DTE, Technetium
Tc 99m Generator, Parent Molybdenum 99 prepared from Fission Produced
Molybdenum 99, Catalog number N8931D, 2D (14.0 curie),
l) Ultra-TechneKow
DTE, UTK-DTE, Technetium Tc 99m Generator, Parent Molybdenum 99 prepared
from Fission Produced Molybdenum
99, Catalog number N8941D, 2D (16.0 curie).
m) Ultra-TechneKow DTE,
UTK-DTE, Technetium Tc 99m Generator, Parent
Molybdenum 99 prepared
from Fission Produced Molybdenum 99, Catalog number
N8951D, 2D (19.0 curie).
CODE
a) Lot 5176,
Exp. 11/18/05; Lot 5178, Exp. 11/21/05; Lot 5180, Exp. 11/25/05; Lot
5182, Exp. 11/28/05;
b) Lot 5176, Exp. 11/18/05; Lot 5180, Exp.
11/25/05;
c) Lot 5176, Exp. 11/18/05; Lot 5178, Exp. 11/21/05; Lot
5179, Exp. 11/23/05; Lot 5180,
Exp 11/25/05;
Lot 5182, Exp.
11/28/05;
d) Lot 5176, Exp. 11/18/05; Lot 5178, Exp. 11/21/05; Lot
5179, Exp. 11/23/05; Lot 5180,
Exp. 11/25/05;
Lot 5182, Exp.
11/28/05;
e) Lot 5176, Exp. 11/18/05; Lot 5178, Exp. 11/21/05; Lot
5179, Exp. 11/23/05; Lot 5180,
Exp. 11/25/05;
Lot 5182, Exp.
11/28/05;
f) Lot 5176, Exp. 11/18/05; Lot 5178, Exp. 11/21/05; Lot
5179, Exp. 11/23/05; Lot 5180,
Exp.11/25/05;
Lot 5182, Exp.
11/28/05;
g) Lot 5176, Exp. 11/18/05; Lot 5178, Exp. 11/21/05; Lot
5180, Exp. 11/25/05; Lot 5182,
Exp. 11/28/05;
h) Lot 5176, Exp. 11/18/05;
Lot 5179, Exp. 11/23/05; Lot 5180, Exp. 11/25/05;
i) Lot 5176, Exp.
11/18/05; Lot 5177, Exp. 11/20/05; Lot 5178, Exp. 11/21/05; Lot
5179,
Exp
11/23/05; Lot 5180, Exp. 11/25/05; Lot 5181, Exp. 11/27/05; Lot 5182, Exp. 11/28/05;
j) Lot 5176, Exp. 11/18/05;
Lot 5177, Exp.
11/20/05; Lot 5178, Exp. 11/21/05; Lot 5179,
Exp. 11/23/05;
Lot
5180, Exp. 11/25/05; Lot 5181, Exp. 11/27/05; Lot 5182, Exp.
11/28/05;
k) Lot 5176, Exp. 11/18/05; Lot 5177, Exp. 11/20/05; Lot
5178, Exp. 11/21/05; Lot 5179,
Exp. 11/23/05;
Lot 5180, Exp.
11/25/05; Lot 5181, Exp. 11/27/05; Lot 5182, Exp. 11/28/05;
l) Lot
5176, Exp. 11/18/05; Lot 5177, Exp. 11/20/05; Lot 5178, Exp.
11/21/05; Lot 5179,
Exp 11/23/05;
Lot 5180, Exp. 11/25/05; Lot 5181,
Exp. 11/27/05; Lot 5182, Exp. 11/28/05;
m) Lot 5176, Exp. 11/18/05; Lot 5177, Exp. 11/20/05;
Lot 5178, Exp. 11/21/05; Lot 5179,
Exp.
11/23/05; Lot 5180, Exp. 11/25/05; Lot 5181, Exp. 11/27/05; Lot
5182, Exp. 11/28/05
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Mallinckrodt Inc, Berkeley, MO
Manufacturer: Mallinckrodt Inc, Maryland Heights,
MO.
REASON Lack of assurance of
sterility: Positive unit found in a media fill run.
VOLUME OF PRODUCT IN
COMMERCE 1,646 generators
DISTRIBUTION Nationwide and
Internationally
PRODUCT Children’s Motrin
Bubblegum Suspension 4 oz bottle, Ibuprofen 100 mg/5ml, OTC, NDC 50580-604-04
CODE
Lot number HHM187 exp 8/06
RECALLING
FIRM/MANUFACTURER McNeil Consumer and Specialty Pharmaceuticals, Division
of McNeil PPC, Fort Washington, PA
REASON Presence of particulate matter:
product intended for destruction due to white fiber material found on packaging
transfer screen was possibly diverted to retail stores.
VOLUME OF PRODUCT
IN COMMERCE Unknown
DISTRIBUTION Unknown
PRODUCT Simply Sleep
Mini-Caplets, (Diphenhydramine HCl) 25mg, 100 mini-caplets per bottle, NDC
50580-843-10
CODE Lot number JFM058 exp
5/06
RECALLING FIRM/MANUFACTURER McNeil Consumer and Specialty
Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA
REASON Presence of particulate matter: product intended
for destruction due to white fiber material found on packaging transfer screen
was possibly diverted to retail stores.
VOLUME OF PRODUCT IN
COMMERCE Unknown
DISTRIBUTION Unknown
PRODUCT Tylenol Sinus Nighttime
Caplets, Each caplet contains Acetaminophen 500 mg, Doxylamine succinate 6.25
mg, Pseudoephedrine HCl 30 mg, 12 count blister card packages,
CODE
Lot number JMM087 exp 7/06
RECALLING
FIRM/MANUFACTURER McNeil Consumer and Specialty Pharmaceuticals, Division
of McNeil PPC, Fort Washington, PA
REASON Mispacked; product intended for
destruction due to foreign object (ball bearing) found in blister card was
possibly diverted to retail stores.
VOLUME OF PRODUCT IN
COMMERCE Unknown
DISTRIBUTION Unknown
PRODUCT Children’s Tylenol
Soft-Chews, (Acetaminophen), 80 mg, 30 tablet bottle, Fruit Flavor, NDC
50580-105-32
CODE Lot number HPM102 exp
8/05
RECALLING FIRM/MANUFACTURER McNeil Consumer and Specialty
Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA
REASON Label
error on declared strength; quantity for other ingredient phenylalanine is
listed as 3 mg instead of as 6mg (product intended for destruction was possibly
diverted to retail stores).
VOLUME OF PRODUCT IN
COMMERCE Unknown
DISTRIBUTION Nationwide
PRODUCT
a) Children’s Tylenol
Oral Suspension, (Acetaminophen), 160 mg/5mL (teaspoon), 4 Fl oz
(120mL), bottles, Bubblegum Yum Flavor, NDC 50580-407-04
b) Children’s Tylenol Oral Suspension,
(Acetaminophen), 160
mg/5mL (teaspoon), 4 Fl oz (120mL), bottles, Cherry Blast Flavor, NDC
50580-123-04
CODE
a) Lot numbers: JLM121 exp
9/06, and JLM122 exp 9/06;
b) JLM123 exp 9/06
RECALLING
FIRM/MANUFACTURER McNeil Consumer and Specialty Pharmaceuticals, Division
of McNeil PPC, Fort Washington, PA
REASON Presence of foreign substance;
pieces of wire tie found, product intended for destruction was possibly diverted
to retail stores.
VOLUME OF PRODUCT IN
COMMERCE Unknown
DISTRIBUTION Nationwide
PRODUCT
a) Prochlorperazine
Edisylate Injection USP 10 mg/2 mL (5 mg/ml) in 2 ml vials. The product
is shipped in
shippers that contain 40 cartons and cartons contain 25
vials, Rx only, NDC 0703-7171-04,
b)
Prochlorperazine Edisylate Injection USP 5 mg/ml in 10 ml vials. The product is shipped 1 vial per carton,
Rx only, NDC 0703-7175-01,
CODE
a) Lot numbers: 03P138, 04A118, 04A125, 04D101, 04D102, 04D111, and 04D129;
b) Lot numbers: 03P115, 04B128, and
04D108
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva
Pharmaceuticals USA, Sellersville, PA
Manufacturer: Sicor Pharmaceuticals, Inc, Irvine, CA,
REASON
Presence of particulate
matter.
VOLUME OF PRODUCT IN COMMERCE 733,972
vials
DISTRIBUTION Nationwide
PRODUCT Children’s Tylenol Flu
Suspension 4 oz bottle. Acetaminophen (APAP) 160 mg, chlorpheniramine maleate (CPM) 1 mg, dextromethorphan HBr
(DXM) 7.5 mg, pseudoephedrine HCl (PSE) 15 mg
per 5 ml suspension, OTC,
CODE Lot number JAM149
exp. 01/06
RECALLING FIRM/MANUFACTURER McNeil Consumer &
Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA
REASON Presence of particulate matter: Product intended for
destruction due to a small piece of black foreign material observed on the
packaging screen was possibly diverted to retail stores.
VOLUME OF PRODUCT
IN COMMERCE Unknown
DISTRIBUTION Unknown
PRODUCT Children's Tylenol Plus
Flu Suspension Bubblegum Flavor 4 oz. Acetaminophen 160 mg per 5 ml,
chlorpheniramine maleate 1 mg per 5 ml, dextromethorphan HBr 7.5 mg per 5 ml,
and pseudophedrine HCl 15 mg per 5 ml, OTC, NDC 50580-202-04
CODE Lot number JAM217 exp 2/06
RECALLING
FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals,
Division of McNeil PPC, Fort Washington, PA.
REASON Presence of particulate
matter: product intended for destruction due to wood found on mesh screen was
possibly diverted to retail stores.
VOLUME OF PRODUCT IN
COMMERCE Unknown
DISTRIBUTION Unknown
PRODUCT Tylenol Arthritis
Extended Relief Caplets 100 count bottles. Each caplet contains acetaminophen
650 mg, OTC, NDC 50580-112-10
CODE Lot number
HAM149 exp 1/06
RECALLING FIRM/MANUFACTURER McNeil Consumer &
Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA
REASON
Presence of particulate matter: product intended
for destruction due to the possibility of broken metal pieces from the
compression punches being compressed in the caplets was possibly diverted to
retail stores.
VOLUME OF PRODUCT IN
COMMERCE Unknown
DISTRIBUTION Unknown
PRODUCT Tylenol Arthritis
Extended Relief Caplets 100 count bottles. Each caplet contains acetaminophen
650 mg, OTC
CODE Lot number HAM086 exp
12/05
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty
Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA
REASON Presence of particulate matter: product intended
for destruction due to the possibility of broken metal pieces from the
compression punches being compressed in the caplets was possibly diverted to
retail stores.
VOLUME OF PRODUCT IN
COMMERCE Unknown
DISTRIBUTION Unknown
PRODUCT Temazepam, USP, 15 mg.
capsules, Item # 0067687. Rx. NDC 49999-045-15
CODE Lot 08406; Exp. 07/31/08.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Lake Erie Medical &
Surgical, Temperance, MI
Manufacturer: Lake Erie Medical & Surgical, Toledo, OH.
REASON
Mislabeling: The product is
labeled as 15 mg capsules, but the package actually contains 30 mg
capsules.
VOLUME OF PRODUCT IN COMMERCE 6
bottles
DISTRIBUTION FL
PRODUCT Infant’s Tylenol
Concentrated Drops Cherry Flavor 1/2 oz. Acetaminophen 80 mg/0.8 ml, OTC
CODE
Lot number JMM075 exp 10/06
RECALLING
FIRM/MANUFACTURER McNeil Consumer and Specialty Pharmaceuticals, Division
of McNeil PPC, Fort Washington, PA
REASON Presence of particulate matter:
Product intended for destruction due lint free cloth found in mixer was possibly
diverted to retail stores.
VOLUME OF PRODUCT IN
COMMERCE Unknown
DISTRIBUTION Unknown
PRODUCT Mylanta Gelcaps, Each
gelcap contains: Calcium carbonate 550 mg and Magnesium hydroxide 125 mg, 50
count Solid Gelcaps bottles, NDC 16837-850-50
CODE Lot number JEM115 exp 4/06
RECALLING
FIRM/MANUFACTURER McNeil Consumer and Specialty Pharmaceuticals, Division
of McNeil PPC, Fort Washington, PA
REASON Defective container; missing
foil inner seal, product intended for destruction was possibly diverted to
retail market.
VOLUME OF PRODUCT IN
COMMERCE Unknown
DISTRIBUTION Nationwide
PRODUCT Infants Tylenol
Concentrated Drops Plus Cold, Each 0.8mL contains Acetaminophen 80 mg and
Pseudoephedrine HC1 7.5mg, ½ Fl oz (15mL) bottles, NDC 50580-503-15
CODE
Lot HJM140 exp 9/05
RECALLING
FIRM/MANUFACTURER McNeil Consumer and Specialty Pharmaceuticals, Division
of McNeil PPC, Fort Washington, PA
REASON Failed pH specification,
product intended for destruction was possibly diverted to retail
market.
VOLUME OF PRODUCT IN
COMMERCE Unknown
DISTRIBUTION Nationwide
PRODUCT Tylenol Allergy Sinus
Day Time Gelcaps, Each gelcap contains Acetaminophen 500 mg, Chlorpheniramine
maleate 2 mg, and Pseudoephedrine HC1 30 mg, Maximum Strength, 48 count blister
pack
CODE Lot HFM048 exp 6/06
RECALLING
FIRM/MANUFACTURER McNeil Consumer and Specialty Pharmaceuticals, Division
of McNeil PPC, Fort Washington, PA
REASON Defective packaging; damage
blister card inspection, product intended for destruction was possibly diverted
to retail market.
VOLUME OF PRODUCT IN
COMMERCE Unknown
DISTRIBUTION Nationwide
PRODUCT Children’s Motrin Oral
Suspension, (Ibuprofen), 100 mg/5 ml (teaspoon), 4 Fl oz (120mL) bottles,
Original Berry Flavor, NDC 50580-601-04
CODE Lot
HCM001 exp 1/06
RECALLING FIRM/MANUFACTURER McNeil Consumer and
Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA
REASON
Subpotent (product intended for destruction was
possibly diverted to retail stores).
VOLUME OF PRODUCT IN
COMMERCE Unknown
DISTRIBUTION Nationwide
PRODUCT Tylenol Allergy Sinus
gelcap. Each caplet contains acetaminophen 500 mg, chlorpheniramine maleate 2
mg, and pseudoephedrine HCl 30 mg, OTC
CODE Lot
number JMM180 exp 7/06
RECALLING FIRM/MANUFACTURER McNeil Consumer
and Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA
REASON
Defective container: product intended for
destruction due a tear in the pouch was possibly diverted to retail
stores.
VOLUME OF PRODUCT IN
COMMERCE Unknown
DISTRIBUTION Unknown
PRODUCT
a) Fougera TRIAMCINOLONE
ACETONIDE LOTION USP, 0.1%, 60 mL, NDC 0168-0337-60, FOR DERMATOLOGIC USE NOT FOR OPHTHALMIC USE, Rx only,
b) Fougera
TRIAMCINOLONE ACETONIDE LOTION USP, 0.025%, 60 mL, NDC 0168-0336-60, FOR
DERMATOLOGIC USE NOT FOR OPHTHALMIC USE, Rx only,
c) Fougera FLUOCINOLONE ACETONIDE TOPICAL
SOLUTION USP, 0.01%,
60 mL, NDC 0168-0059-60, FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC
USE, Rx only,
d) Fougera CLOBETASOL PROPIONATE TOPICAL SOLUTION USP, 0.05%, 50
mL, NDC 0168-0269-50, FOR USE ON THE SCALP FOR DERMATOLOGIC USE ONLY NOT FOR
OPHTHALMIC USE, Rx only,
e) Fougera BETAMETHASONE VALERATE
LOTION USP, 0.1% (Potency
expressed as betamethasone), 60 mL, NDC 0168-0041-60, FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE,
Rx only
f)
Fougera BETAMETHASONE DIPROPIONATE LOTION USP, 0.05% (Potency expressed
as betamethasone), 60 mL, NDC 0168-0057-60, FOR DERMATOLOGIC USE
ONLY NOT FOR OPHTHALMIC USE, Rx only
CODE
a)
Lot T431, exp. 8/07;
b) Lot S999, exp. 8/07;
c) Lot T600, exp. 4/07;
d)
Lot T610, exp. 3/07;
Lot T611, exp. 3/07;
e) Lot T480, exp. 9/08; Lot
T481, exp. 9/08;
f) Lot T469, exp. 9/08
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Altana Inc., Melville, NY,
Manufacturer: Altana Inc., Hicksville, NY.
REASON Defective Dropper: The dropper plug does not meet
specification in that the container/closure component cannot ensure an adequate
opening for dispensing the drug product.
VOLUME OF PRODUCT IN
COMMERCE 66,692 units
DISTRIBUTION Nationwide
WEEK ENDING JANUARY 21
PRODUCT
a) Cardioplegia infusion
solutions including: Cold Cardioplegia, Warm Cardioplegia, Blood
Cardioplegia 1, Blood Cardioplegia 2, Cardioplegia Base 1, Cardioplegia Base
2, Cardioplegia Base, Cardioplegia Reperfusion, Cardioplegia High
Potassium, Cardioplegia Low Potassium, Cardioplegia #1, Cardioplegia
#2 Cardioplegia #3; Maintenance Cardioplegia, Enriched Cardioplegia,
Cardioplegia Base Enriched. Products are manufactured to order and
packaged in clear, plastic infusion bags in various volumes, and
additionally labeled with component formula and the specified consignee.
b) Oxytocin Infusion Bags, packaged as
Oxytocin 10
units, Oxytocin 20 units, Oxytocin 30 units, Oxytocin D5 1/2 NS, Oxytocin
in Lactated Ringers. Products are manufactured to order and packaged in
clear, plastic infusion bags in various volumes, and additionally
labeled with component formula and the specified consignee
c) Magnesium-containing injectable
products including: Magnesium
1 GM, Magnesium 2 GM, Magnesium Sulfate 2 GM, Magnesium 4 GM,
Hydration-Magnesium in D5W, Magnesium Infusion, Magnesium in Lactated
Ringers. Products are manufactured to order and packaged in clear,
plastic infusion bags in various volumes, and additionally labeled with component formula and the specified
consignee.
d)
Dialysate solutions including: Citrate Dialysate, Heparin Dialysate, Pediatric
Dialysate, Hydration
Dialysate #1, Hydration Dialysate #2, CRRT Dialysate, CVVHD
(Dialysate) 300, CVVHD (Dialysate) 342, CVVHD Pediatric Formula (Normocarb), CVVHD Formalin #1, CVVHD Formalin #2,
CVVHD Formalin #3, CVVHD Non-Standard, CVVHD D5W, CVVHD 1/2 NS, CVVHD
NS.
Products are manufactured to order and packaged in clear, plastic infusion bags in various volumes
and additionally labeled with
component formula and the specified consignee.
e)
Antibiotic Irrigation, packaged in 1 Liter clear plastic bags
and bottles. Products are manufactured
to order and additionally labeled
with component formula and the specified consignee.
f) Bupivicaine 0.25 % and 0.5% Infusion
Solutions, also sold as
Pain Bags (Bupivicaine 0.25 %). Products are manufactured to order and
packaged in clear, plastic infusion bags in various volumes, and
additionally
labeled with component formula and the specified consignee.
g) Diltiazem "piggyback" Infusion bags, containing
Diltiazem 5mg/ml injection. Products are manufactured to order and
additionally labeled with component formula and the specified consignee.
h) Norepinephrine Bitartrate (piggyback)
Infusion Bags,
1 mg/ml. Products are manufactured to order and additionally labeled
with component formula and the specified consignee.
i) Promethazine, manufactured as 25 mg/ml
and 50mg/ml vials. Products are manufactured to order and labeled **FOR IM/IV USE ONLY** and
additionally labeled with component formula and the specified consignee.
CODE
a) Expiration Date 9/1/05 to
10/15/05;
b) Expiration Date codes between 8/31/05 and 10/16/05;
c)
Expiration date codes between 8/31/05 and 10/16/05;
d) Expiration date
codes are between 8/21/05 and 10/16/05;
e) Expiration date codes between 8/31/05 and 10/16/05;
f) Expiration date codes between
8/31/05 and
10/16/05;
g) Expiration date codes between 8/31/05 and 10/16/05;
h)
Expiration date codes between 8/15/05 and 9/30/05;
i) Expiration date
codes between 8/15/05 and 9/30/05.
RECALLING
FIRM/MANUFACTURER Central Admixture Pharmacy Services, Inc., Lanham, MD, REASON
Bacterial
contamination.
VOLUME OF PRODUCT IN COMMERCE 33,682
units
DISTRIBUTION MD, VA, DE and D.C.
PRODUCT
a) Hydrocodone
Bitartrate/APAP, 5/500 mg, 15-unit dose packages, NDC #0406035701
b) Hydrocodone
Bitartrate/APAP, 10/650 mg, 15-unit dose
packages, NDC #0406036101
CODE
a) Lot #
0357J50485, Exp. Date 12/05/06;
b) Lot # 0361J52296, Exp. Date
12/05/06
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Murfreesboro Pharmaceutical Nursing Supply, Murfreesboro, TN
Manufacturer: Tyco Healthcare
Mallinckrodt, Inc., Hobart, NY.
REASON Mispackaging: Two unit dose packaged drugs were
placed into incorrectly labeled boxes.
VOLUME OF PRODUCT IN
COMMERCE 598 units
DISTRIBUTION TN
WEEK ENDING JANUARY 28
PRODUCT Adrenalin Chloride
Solution, Epinephrine Nasal Solution, USP, l mg per mL, 30mL, Vasoconstrictor,
For Topical Application 1:1000, Rx only, NDC 61570-300-31
CODE Lot numbers: 01184M, exp 01/06; 009N4M, exp 03/06;
02325M, exp 08/06
RECALLING FIRM/MANUFACTURER
Recalling
Firm: King Pharmaceuticals, Inc., Bristol, TN
Manufacturer: Parkedale Pharmaceuticals, Inc., Rochester, MI.
REASON
Split cap thread defects
which may lead to a lack of sterility assurance.
VOLUME OF PRODUCT IN
COMMERCE 34,389 units
DISTRIBUTION Nationwide
PRODUCT Children's Motrin Dye
Free 4 oz bottles Berry Flavor
CODE Lot number
FPM009 exp 11/05
RECALLING FIRM/MANUFACTURER McNeil Consumer &
Specialty Pharmaceuticals, Division of McNeil, Fort Washington, PA
REASON
Product intended for destruction due to foreign
organic material/black speck was possibly diverted to retail
stores.
VOLUME OF PRODUCT IN
COMMERCE Unknown
DISTRIBUTION Unknown
PRODUCT Citrucel FiberShake
Chocolate .38 oz Packets which are distributed individually as well as in a 5
count starter kits. Methylcellulose (a non-allergenic fiber) 2g...Bulk-forming
laxative, Uses***, Warnings***, Directions***, Inactive ingredients***
CODE
All lots: Case lots with have an A or N() after the
lot number: Lot -- Exp. Date: 05A075 -- MAR-07; 05A076 -- MAR-07; 05B212 --
APR-07; 05F002 -- JUL-07; 05B210 -- APR-07; 05B211 -- APR-07; 05D056 -- MAY-07;
05A049 -- MAR-07; 05F001 -- JUL-07; 05A045 -- FEB-07; 05A046 -- MAR-07; 05A048
-- MAR-07; 05C162 -- MAY-07; 05C164 -- MAY-07; 05F003 -- JUL-07; 05C160 --
APR-07; 05C161 -- APR-07; 05C163 -- MAY-07; 05D057 -- MAY-07
RECALLING
FIRM/MANUFACTURER
Recalling Firm: GlaxoSmithKline, Parsippany, NJ
Manufacturer:
JB Laboratories, Inc.,
Holland, MI.
REASON During
stability testing of non-commercial/undistributed lots, packets were found to
exceed "Total Coliforms" specification of NMT 10 cfu/g at the 12 month station.
All commercial lots are being recalled.
VOLUME OF PRODUCT IN
COMMERCE 4,429,192 packets
DISTRIBUTION Nationwide and
PR
PRODUCT Infant's Tylenol
Concentrated Drops Cherry Flavor 1/2 oz Acetaminophen 80 mg/0.8 ml, OTC,
CODE
Lot number JMM075 exp 10/06
RECALLING
FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals,
Division of McNeil, Fort Washington, PA
REASON Presence of particulate
matter: Product intended for destruction due lint free cloth found in mixer was
possibly diverted to retail stores.
VOLUME OF PRODUCT IN
COMMERCE Unknown
DISTRIBUTION Unknown
PRODUCT
a) Children's Tylenol
Plus Cold Nighttime Suspension 4 oz. Grape Flavor,
b) Children's Tylenol Plus Cold Daytime
Suspension 4 oz Fruit
Flavor,
c) Children's Tylenol Plus Cough and Cold Suspension 4 oz Cherry Flavor,
d) Children's
Tylenol Plus Flu Suspension4 oz Bubblegum Flavo
CODE
a) Lot numbers JLM267 exp 9/06, JLM130 exp 9/06,
and JLM266 exp 9/06;
b) Lot numbers JLM270 exp 9/06 and JMM177 exp
10/06;
c) Lot numbers JLM200 exp 9/06 and JLM201 exp 9/06;
d) Lot
number JLM248 exp 10/06
RECALLING FIRM/MANUFACTURER McNeil Consumer
& Specialty Pharmaceuticals, Division of McNeil, Fort Washington, PA
REASON
Product intended for destruction due to tamper
evident issue was possibly diverted to retail stores.
VOLUME OF PRODUCT IN
COMMERCE Unknown
DISTRIBUTION Unknown
PRODUCT Members' Mark brand
Arthritis Pain Relief acetaminophen extended-release tablets 650 mg. pain
reliever in bottles of 200, OTC; NDC 68196-544-82
CODE Lot 5LE0031; exp. 08/07
RECALLING
FIRM/MANUFACTURER Perrigo Company, Allegan, MI
REASON Defective
Container: The tamper-evident seal on the mouth of the bottle may not be
intact.
VOLUME OF PRODUCT IN COMMERCE 5,472
bottles
DISTRIBUTION Nationwide
PRODUCT Equaline first aid
antibiotic ointment --- polymyxin B sulfate --- bacitracin zinc --- first aid
antibiotic ointment --- NET WT 1 OZ (28.4 g) --- compare to Polysporin active
ingredients --- Active Ingredient (each gram contains) --- Bacitracin zinc 400
units ... Polymyxin B Sulfate 5,000 units
CODE Lots 5F053 (exp. 6/08), 5F055 (exp. 6/08), 5J050 (exp.
10/08)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Taro
Pharmaceuticals U.S.A., Inc, Hawthorne, NY
Manufacturer: Taro
Pharmaceuticals, Inc, Brampton, Canada.
REASON Labeling: label error on declared strength of active
ingredients bacitracin zinc and polymyxin B sulfate.
VOLUME OF PRODUCT IN
COMMERCE 20,916 units
DISTRIBUTION Nationwide
PRODUCT Maximum Strength Tylenol Cold Nighttime Complete Formula 24 Caplets per blister card
CODE Lot number HJM064 exp 4/06
RECALLING
FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals,
Division of McNeil, Fort Washington, PA
REASON Mispackaging: Product
intended for destruction due to blister cards from HHM227 (same product) were
found in the on line rework bin during startup of batch HJM064 was possibly
diverted to retail stores.
VOLUME OF PRODUCT IN
COMMERCE Unknown
DISTRIBUTION Unknown
PRODUCT Altace, Ramipril
Capsules, 2.5 mg, 100 capsule bags
CODE Lot
052557B, 052230B, 053676A, 053676B, 055948A, 055023, 055948B, 053803, 052230A,
052557A. All lot codes have an expiration date of 10/31/06.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Amerisource Health Services,
Columbus, OH
Manufacturer: Aventis
Pharmaceuticals, Inc., Kansas City, MO.
REASON Labeling: The individual blister cards may contain
missing or not clearly printed characters in the expiration dates.
VOLUME
OF PRODUCT IN COMMERCE 38 units of 100 capsules
each
DISTRIBUTION Nationwide
PRODUCT
a) DDF Doctor's
Dermatologic Formula, Organic Sun Protection SPF 30 --- for Sensitive Skin --- Super Antioxidant Complex, Oil &
Fragrance-Free --- Meets
EU Standards for UVA --- net wt. 4 oz. 113.4 g --- Active ingredients:
Titanium Dioxide 2.5% ---Zinc Oxide 4%, UPC 0 60748 00040 3,
b) DDF Doctor's Dermatologic Formula, Moisturizing
Photo-Age
Protection SPF 30, Delays Skin Aging,
Restores Moisture --- Super
Antioxidant Complex, Meets EU Standards For UVA, net. wt. 4 oz. 113.4
g, Active ingredients: Avobenzone 1%, Octinoxate 7.5%, Octisalate 5%,
Octocryene 6%, UPC 0 60748 00039 7,
c) DDF Doctor's
Dermatologic Formula, Matte Finish, Photo-Age, Protection SPF 30 ---
Minimizes Shine, Super Antioxidant Complex, Oil and Fragance-Free, Meets
EU Standards for UVA, net wt. 4 oz. 113.4 g, Active ingredients: ---
Avobenzone 1% --- Octinoxate 7.5% --- Octisalate 5% --- Octocrylene 6%, UPC 0 60748 00038 0, Recall # D-131-6;
d) DDF Doctor's Dermatologic
Formula, Protective Eye
Cream SPF 15 --- 0.5 fl. oz. 15 ml ---
Active ingredient: Octinoxate 5% --- Octisalate 1% ---
Zinc Oxide 2%
e) DDF Doctor's Dermatologic Formula, Fade Gel 4 ---Hydroquinone 2% --- Proven Lightener, Evens Skin
Tone --- Fades Age
Spots --- 0.5 fl. oz. 15 ml ---Active Ingredient: Hydroquinone 2%, UPC bar
code 0 60748 00032 8
f) DDF Doctor's Dermatologic
Formula, Fade Cream, SPF 30 --- Hydroquinone 2%, Minimizes Age
Spots, Prevents Recurrence, Enriched Moisturizer, net wt. 1.7 oz. 48 g --
Active Ingredients:
Avobenzone 1% --- Hydroquinone 2% --- Octinoxate 7.5% --- Octisalate 4% --- Octocrylene 5% ---
Oxybenzone 1.5%, UPC 0
60748 00030 4,
g) DDF Doctor's Dermatologic Formula,
Glossy Lip Therapy, SPF 15 --- Plumps --- Protects ---
Moisturizes, net
wt. 0.25 oz. 7 g --- Active Ingredients: Octinoxate 5% --- Octisalate 3% ---
titanium Dioxide 1%, UPC bar code 0 60748 00041 0,
CODE
All lots & sizes on the market
RECALLING
FIRM/MANUFACTURER
Recalling Firm: HDS Cosmetics, Inc., Yonkers, NY
Manufacturer: HDS Cosmetics, Inc., Harrison, NY.
REASONFirm does not have adequate stability
data to support 2 year expiry period for the OTC products.
VOLUME OF
PRODUCT IN COMMERCE Approx. 218,189
units
DISTRIBUTION Nationwide
PRODUCT Tylenol Sinus Severe
Congestion 24 Caplets per blister card, (Acetaminophen 325 mg), OTC, NDC
50580-442-24
CODE Lot number JLM095, exp.
8/06
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty
Pharmaceuticals, Division of McNeil, Fort Washington, PA
REASON CGMP
Deviations: Product intended for destruction due to there was a power failure
causing an air handling system failure in coating vector pan/exceeded 50 degrees
with erratic spray rate was possibly diverted to retail stores.
VOLUME OF
PRODUCT IN COMMERCE Unknown
DISTRIBUTION Unknown
PRODUCT Children's Motrin Cough
Grape Suspension 4 oz , (ibuprofen 100mg & pseudoephedrine HCl 15mg), OTC,
NDC 50580-903-04
CODE Lot number JPM182, exp.
10/06
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty
Pharmaceuticals, Division of McNeil, Fort Washington, PA
REASON CGMP
Deviations: Product intended for destruction due to documentation error was
possibly diverted to retail stores.
VOLUME OF PRODUCT IN
COMMERCE Unknown
DISTRIBUTION Unknown
PRODUCT Extra Strength Tylenol
Caplets 2 count pouches, (Acetaminophen 500mg), OTC
CODE Lot number LAM083, exp. 10/08
RECALLING
FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals,
Division of McNeil, Fort Washington, PA
REASON Mispackaging: Product
intended for destruction due to out of specification result because 3 caplets
were released into packaging instead of 2 caplets which was possibly diverted to
retail stores.
VOLUME OF PRODUCT IN
COMMERCE Unknown
DISTRIBUTION Unknown