FEBRUARY
2001
WEEK ENDING FEBRUARY 2
The
Food and Drug Administration (FDA) is urging individuals, health care
organizations and medical product distributors to stop dispensing and/or
distributing certain injectable medications marketed by Phyne Pharmaceuticals
of Scottsdale, Ariz. AMRAM Inc. of Rathdrum, Idaho manufactured these products
for Phyne Pharmaceuticals, who was their sole customer.
On
December 14, 2000, AMRAM Inc. notified Phyne Pharmaceuticals that AMRAM Inc.
was recalling these products because they were manufactured under sub-standard
conditions. FDA is issuing today's warning because Phyne Pharmaceuticals has
delayed taking prompt and appropriate action to remove these products from the
market.
Anyone
in possession of these products is urged to contact and to return the products
to Phyne Pharmaceuticals at 7950 East Red Field Rd., Scottsdale, Ariz. 85267,
(800) 345-3391 or 480-998-4142, FAX (480) 443-4775. Phyne Pharmaceuticals has stated
they will be providing specific return instructions to their customers by an
"Urgent Voluntary Drug Recall" letter dated January 25, 2001.
The
following is the most up-to-date list of products under recall by Phyne
Pharmaceuticals. Some of the products are labeled with both AMRAM, Inc. and
Phyne Pharamceuticals; however, some may bear one or the other company's name
as the manufacturer and/or distributor with or without the other company's name
listed. All lot numbers and codes, strengths and sizes and expiration dates of
the following injectable products are included in this recall:
Adenosine
Monophosphate
Ascorbic
Acid Injection
Beet
Ascorbic Acid Injection
Biotin
Colchicine
Vitamin
B-12(Cyanocobolamin)
Dexpanthenol
Disol,
USP Brand of EDTA
Echinacea
Homeopathic Injection
Edetate
Disodium
Endocrine
Adrenal
Cortex Extract (ACE)
Folic
Acid
Germanium
Sesg.(Sesguloxide)
L-Glutathione
or Glutathione
Human
Chorionic Gonadotropin
Hydrochloric
Acid
Iron
59 Injection
Liver
Injection, Crude
Lypo-Vite
Injection
Magnesium
Chloride Injection
M.I.C.
Procaine
Hydrochloride Injection
Pyridoxine
HCL (B-6)
Sodium
Thiosalicylate
Superoxide
Dismutase (S.O.D.)
L-Taurine
Injection
Thiamine
HCL
Thymus
Extract
Choline
Chloride
Diphenhydramine
Glycyrrhizen
Chlorpheniramine
Injection
Hydrogen
Peroxide
Hydroxocobalamin
MIC
with Folic Acid
Niacin
Pangamic
Acid
Riboflavin
Patients
who believe they might have been injured by these products should immediately
consult with their health care provider. FDA is aware of three serious injuries
associated with the use of one of the recalled products, Colchicine, labeled as
containing .5mg/ml but actually formulated at a concentration of 5mg/ml.
WEEK
ENDING FEBRUARY 9
PRODUCT: TegretolÆ (carbamazepine USP), 200 mg tablets, in bottles of 100 and
1,000 tablets. This Rx product is
indicated for use as an anticonvulsant associated with epilepsy. 100 tablets:
#6505-00-232-5046. 1000 tablets: #6505-00-408-8915 EXTENSION TO D-059-1.
CODE: LOT NOS. Initial lots recalled on 9/18/00:
150B2289 (10/2002), 155B2289 (10/2002), 121B9991 (4/2002), 128B1120 (6/2002),
137B1238 (6/2002), 144B1825 (8/2002), 156B3063 (10/2002), 158B3063 (10/2002),
170D4247 (1/2003), 1T237018 (9/2001). *** ADDITIONAL LOTS included in recall
expansion of 11/17/00:
179D5121
(EXP. 2/2003) in bottles of 100s
179D5216
(EXP. 2/2003) in bottles of 1000s.
MANUFACTURER: Novartis Pharmaceutical Corp. (Suffern,
NY).
DISTRIBUTION: Nationwide.
QUANTITY: A total of 172,586 bottles (150,223 bottles of
100s and 22,363 bottles of 1000s) for the 10 initial lots of recalled TegretolÆ
200
mg were distributed (by lot) as follows:
Lot #150B2289: 3784 bottles of 1000s
Lot #155B2289: 3787 bottles of 1000s
Lot #121B9991: 3641 bottles of 1000s
Lot #128B1120: 36,734 bottles of 100s
Lot #137B1238: 3750 bottles of 1000s
Lot #144B1825: 3756 bottles of 1000s
Lot #156B3063: 37,444 bottles of 100s
Lot #158B3063: 38,137 bottles of 100s
Lot #170D4247: 37,908 bottles of 100s
Lot #1T237018: 3645 bottles of 1000s
***
Additional 2 lots: Lot #179D5216: 2689 bottles of 1000s were distributed
between 9/11/00 and 10/23/00
Lot
#179D5121: 11,047 bottles of 100s were distributed between 4/26/00 and 5/5/00.
REASON: Dissolution failure.
PRODUCT: Pancrelipase 16,000 ECM Capsules, in 100 count bottles. Indicated for use for patients with
pancreatic enzyme deficiency.
CODE: Lot 40629 exp. 12/00.
MANUFACTURER: Mutual Pharmaceutical Company, Inc.,
Philadelphia, PA.
DISTRIBUTION: Nationwide.
QUANTITY: 3,125 bottles.
REASON: Dissolution failure.
PRODUCT: ZERIT Capsules (Stavudine), 40 mg capsules, 60 capsules per bottle
CODE: Lot #MCS08, EXP MAR 2002. Bristol-Myers Squibb Immunology a Bristol-Myers
Squibb Company.
MANUFACTURER: Bristol-Myers Squibb, Princeton, NJ.
RECALLED BY: R & S Sales, Inc., Fountain Run, KY
DISTRIBUTION: NY, CA, KY, MN, WI, IL, CT, LA, PA, SC, TX
and MI.
QUANTITY: 3,756 bottles.
REASON: The product has been relabeled with an extended
expiration date.
PRODUCT: (OTC) Femgest ô Progesterone Cream, 2 oz (57 g) jars and 1.5 teaspoon
units in pink sample blister packages.
CODE: 2 oz. Jars: LOT NOS. 13410, 13449, 13576, &
13559; Product No.5717. Sample blister packs: Lot No.13410; Product No. 5616.
MANUFACTURER: Home Health, Bohemia, NY. (A subsidiary of
NBTY, Inc.).
RECALLED BY: NBTY, Inc., Bohemia, NY
DISTRIBUTION: NY, NJ, MA, CT, NH, MD, MI, IN,GA, FL, TX,
AZ, IA, WI, UT, CO, MO, OR, WA, CA.
QUANTITY: Approximately 30,000/2 ounce jars and 50,000
blister packs.
REASON: Mold contamination.
PRODUCT: DILANTIN 100 MG KAPSEALS (EXTENDED PHENYTOIN SODIUM CAPSULES,
USP). ANDA 84-349
BOTTLES
OF 1000'S
BOTTLES
OF 100'S.
CODE:
LOT
NO. EXP. DATE
10039F 2/01
00299F 8/01
MANUFACTURER: WARNER LAMBERT (PARKE-DAVIS)
FAJARDO, PR.
RECALLED BY: PFIZER INC., NEW YORK, NY
DISTRIBUTION: Nationwide, South Africa and Thailand.
QUANTITY: 4,032 Bottles of lot 10039F and 40,464 bottles of
lot 00299F.
REASON: Dissolution failure.
PRODUCT: TheraPatch Vapor nose & chin Cough Suppressant containing 14
strips active ingredients: Camphor 4.7% and Menthol 2.6%;
TheraPatch
Vapor chest Cough Suppressant containing 7 patches active ingredients: Camphor
4.7% and Menthol 2.6%; Triaminic Vapor Patch, Menthol Scent containing 6
patches per carton; active ingredients: Camphor 4.7% and Menthol 2.6%; product
is labeled as being distributed by Novartis Consumer Health,Inc., Summit, NJ
The
products are described on the TheraPatch labels as "Ointment on a
breathable cloth patch" or "Ointment On A Breathable
Adhesive
Cloth Patch".
CODE: All lots manufactured during the last 18 months.
MANUFACTURER: LecTec Corporation , Edina, MN.
DISTRIBUTION: Nationwide.
QUANTITY: 6043 cases of 24 retail packages per case of
TheraPatch Vapor Chest; 1810 cases of 24 retail packages per case of TheraPatch
Vapor nose/chin; 329 cases of 36 retail packages per case of TheraPatch Vapor
nose/chin.
REASON: Pouch seal failures (opening along top, sides
and/or bottom).
WEEK
ENDING FEBRUARY 23
PRODUCT: (Rx) Cytomel Liothyronine sodium tablets, 25 MCG, bottles of
100.
CODE: Lot No. 549D16, Exp. 05/01.
MANUFACTURER: Schering Canada, Inc., Pointe-Claire,
Quebec H9R 1B4, Canada.
RECALLED BY: Jones Pharma, Inc., St. Louis, MO
DISTRIBUTION: Nationwide to wholesale distributors and
physicians.
QUANTITY: 23,748 bottles.
REASON: Subpotency (@ 20 month of expiry).
PRODUCTS:
(Rx)
Adenosine Mono-Phosphate Injection, 25 mg/mL, 30 mL vial
(Rx)
Ascorbic Acid Injection, USP, 500 mg/mL, 50 mL vial
(Rx)
Adrenal Cortex Extract (ACE), 30 mL vial
(Rx)
Beet Ascorbic Acid Injection, USP, 500 mg/mL, 50 ml vial
(Rx)
Biotin Injection,10mg/mL, 30 mL vial
(Rx)
Dexpanthenol Injection, 250 mg/mL, 30
mL vial
(Rx)
DI-SOL Injection, USP brand of EDTA, 150 mg/mL, 100 mL vial
(Rx)
Echinacea Homeopathic Injection, 30 mL vial, 1:1 Mascerated
(Rx)
Edetate Disodium Injection, USP, 3 g/20mL(150mg/mL), 20 mL vial
(Rx)
Endocrine Injection, 30mL vial
(Rx)
Folic Acid Injection, 10 mg/mL, 30 mL vial
(Rx)
Germanium Sesg. (Sesguloxide), 15.5
mg/mL, 30 mL vial
(Rx)
(L) Glutathione Injection, 60mg/mL, 30 mL vial
(Rx)
HCL Injection, Diluted Hydrochloric Acid, 2 mg/mL, 100 mL vial
(Rx)
Human Chorionic Gonadotropin for Injection, USP, 10,000 units, 10 mL
(Rx)
Iron 59 Injection, (Ferrous Gluconate 5.9 mgÖ), 30 mL vial
(Rx)
Liver Injection Crude (Cyanocobalamin 2 mcg per mLÖ), 30 mL vial
(Rx)
Lypo-Vite Injection, ( cyancobalamin 100 mcg Ö) 30 mL vial
(Rx)
Magnesium Chloride Injection, 200 mg/mL, 50 mL vial
(Rx)
M.I.C. Injection, Each 2mL contains L-Methionine 50mg, Inositol 100mg, Choline
Chloride 100 mg, Benzyl 1.5%, 50 mL vial
(Rx)
Procaine Hydrochloride Injection, USP, 2%, 100 mL vial
(Rx)
Pyridoxine HCL (B-6) Injection, 100 mg/mL, 30 mL vial
(Rx)
Sodium Thiosalicylic Injection, 100 mL/mL, 30 mL vial
(Rx)
Superoxide Dismutase (S.O.D.) 10 mg/mL, 30 mL vial
(Rx)
L-Taurine Injection, 50mg/mL, 100 mL vial
(Rx)
Thiamine HCL Injection, (B-1) 100mg/mL, 30 mL vial
(Rx)
Vitamin B-12 5000 Injection, 5000mg/mL Cyanocobalamin USP, 100mL vial
(Rx)
Thymus Extract Injection, 10 mg/mL, 30 mL vial
(Rx)
Choline Chloride Injection, 30 mL vial
(Rx)
Diphenhydramine Injection, 30 mL vial
(Rx)
Glycyrrhizen Injection, 30mL vial
(Rx)
Chlorpheniramine Injection
(Rx)
Hydrogen Peroxide Injection, 11cc per 100mL vial
(Rx)
Hydroxocobalamin Injection, 30 mL vial
(Rx)
MIC with Folic Acid Injection, 50 mL vial
(Rx)
Niacin Injection, 30 mL vial
(Rx)
Pangamic Acid Injection, 500 mg/mL, 30 mL vial
(Rx)
Riboflavin Injection, 30 mL
CODES: All lot numbers and codes, strengths, sizes and
expiration dates.
MANUFACTURER: Phyne Pharmaceuticals, Inc., Scottsdale,
AR.
DISTRIBUTION: STATES OF AK, AL AR, AZ, CA, CO, CT, WASH
DC, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC,
ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI,
WV, PR, CANADA, EUROPE.
QUANTITY: Undetermined.
REASON: Current good manufacturing practice deviations
including, but not limited to, lack of assurance of sterility.
PRODUCT: a) ACYCLOVIR FOR INJECTION 500 MG, 10 ML VIAL, NDC 59911-2465-02,
RX.
b)
ACYCLOVIR FOR INJECTION 1 GRAM, 10 ML VIAL, NDC 59911-2466-02, RX.
CODE:
a)
Lot No. 425-001, Exp. Date
2/01;
Lot No. 425-419 Exp.
Date 4/01;
Lot
No. 464-769 Exp. Date
7/01;
b)
Lot No. 425-020 Exp. Date
1/01;
Lot No. 425-420 Exp. Date
1/01;
Lot No. 426-039 Exp. Date
1/01.
MANUFACTURER: Lederle Parenterals, Inc., Carolina, PR.
RECALLED BY: Wyeth-Ayerst Laboratories, Philadelphia, PA
DISTRIBUTION: Nationwide.
QUANTITY: Approximately 13,121 units.
REASON: Discoloration.
PRODUCT: (RX) Dilantin Capsules, KAPSEALS (Extended Phenytoin Sodium Capsules,
USP)100mg, 100 and 1000 units bottles.39F,.
CODE: LOT NO. 10039F, EXP. Date 2/01; Lot No. 00299F, Exp. Date
8/01.
MANUFACTURER: Warner Lambert (Parke-Davis), Fajardo,
PR.
RECALLED BY: PFIZER Inc., New York, NY
DISTRIBUTION: Nationwide, 18 bottles to South Africa and
Thailand of LOT 10039F.
QUANTITY: 4,032 bottles of lot 10039F and 40,464 bottles of
lot 00299F.
REASON: Dissolution Failure.
PRODUCT: Levsinex 0.375 mg (Hyoscyamine Sulfate USP 0.375 mg), 100 (extended
release) Timecaps Capsules per bottle.
CODES:
OEO2119 (expiration date 1-02)
OHO3126 (expiration date 4-02)
OHO3170 (expiration date 5-02)
MANUFACTURER: Schwarz Pharma, Inc., Seymour, IN .
RECALLED BY: RightPak, Inc., Madison, WI
DISTRIBUTION: Nationwide and Puerto Rico.
QUANTITY: 1,409 bottles.
REASON: Product packaged with incorrect insert, providing
incorrect description of capsules.
PRODUCT: Children's Advil(tm)Suspension, brand of Ibuprofen, Grape flavored,
100 mg/5 ml, packaged in 4 ounce plastic bottle, 36 bottles/case, indicated for
pain relief and fever reduction.
CODES: Lot No. 99231.
MANUFACTURER: Whitehall Robins Healthcare, Richmond, VA.
RECALLED BY: Whitehall Robins Healthcare, Richmond, VA
DISTRIBUTION: VA, PA, NJ,CT,RI,MD, NY,DE,WV,NC,NH,SC and
PR.
QUANTITY: 8,640 bottles.
REASON: Some of the OTC product may be subpotent.
PRODUCT: a) PremarinÆ tablets (conjugated estrogens tablets), 1.25mg, 1,000
count.
b) PremarinÆ
tablets (conjugated estrogens tablets), 2.5mg, 100 count bottles.
CODE: a) LOT NOS. 00344, Exp. Date: 08/03; and 01065,
Exp. Date: 02/04; b) LOT NOS. 00430, Exp. Date: 10/03.
MANUFACTURER: Ayerst Laboratories, Div. Of Wyeth-Ayerst
Pharmaceuticals, Inc., Rouses Point, NY. And Wyeth Pharmaceuticals Co.,
Guayama, Puerto Rico.
RECALLED BY: McKesson HBOC, Memphis, TN
DISTRIBUTION: Ninety wholesalers within the United
States.
QUANTITY: a) Lot 00344: 1,198 bottles; Lot 01065: 2,388 bottles. b) Lot 00430: 2,932 bottles.
REASON: Manufacturer’s dissolution failure.