SEPTEMBER 2001
WEEK ENDING SEPTEMBER 1
PRODUCT AND CODE: Fluocinolone Acetonide
Ointment USP, 0.025%, in 15 gram and 60 gram tubes, distributed under the E.
Fougera & Co. label. CODE: Lot
G018, expiration date January 2003. 15 g
tubes: NDC 0168-0064-15, 60 g tubes:
REASON: Lack of Homogeneity Leading to Super-Potency..
MANUFACTURER: Altana Inc., Hicksville, NY
RECALLED BY: Altana Inc., Melville, NY
DISTRIBUTION: Nationwide
QUANTITY: 24,991 - 15 g tubes and 22,740 - 60 g tubes were
distributed
PRODUCT AND CODE: LORAZEPAM Tablets, USP,
0.5mg, NDC #61392-455-39, packaged as 30 tablets per 'bingo' card, 140 cards
per case. Code: Lot Number: 18291 Exp Date: 5/31/2003
REASON: CONTAINER DEFECT; The plastic material used to
repackage the individual tablets is de-laminating.
MANUFACTURER/RECALLING FIRM: Geneva Pharmaceuticals,
Broomfield, CO
RECALLED BY: Heartland Repack Services, Toledo, OH
DISTRIBUTION: Nationwide
QUANTITY: 10,588 cards
PRODUCT AND CODE: Oxygen, USP, compressed medical
gas, sold in "E" Cylinders, Lot 193SFS10181
REASON: Partially filled and/or empty cylinders released
for sale.
MANUFACTURER/RECALLING FIRM: Air Liquide America
Corporation, Houston, TX
DISTRIBUTION: CA
QUANTITY: 88 cylinders
PRODUCT AND CODE: Yellow Rockets Tablets,
200 mg Caffeine. The product is sold in 100 count, 250 count, and 500 count
bottles.
The
label states that the product is manufactured for T&M Distributors, Council
Bluff, IA. Code: Lot 10293 exp. 2/03
REASON: STABILITY: There is no Data to support labeled
EXPIRY DATE
MANUFACTURER/RECALLING FIRM: Nittany Pharmaceuticals,
Inc., Milroy, PA
DISTRIBUTION: IA
QUANTITY: 1083 bottles
PRODUCT AND CODE: Overtime Stimulant
tablets, 200 mg caffeine. The product is sold in 100 count and 500 count
bottles. The label
states
that the product is distribured by BDI Pharmaceuticals, A Division of Body
Dynamics Inc, Carmel, IN. Lot 6085 exp. 7/01 and
Lot
10362 exp. 2/03
REASON: STABILITY: There is no Data to support LABELED
EXPIRY DATE
MANUFACTURER/RECALLING FIRM: Nittany Pharmaceuticals,
Inc., Milroy, PA
DISTRIBUTION: IN
QUANTITY: 125 bottles
PRODUCT AND CODE: Monsel Solution (Ferric
Subsulfate Solution). The product is sold in an 8 ml vial in cases of 12 vials.
The NDC number is 48783-112-08. Code: Lot #57952 exp. 1/02
REASON: SUPER-POTENT FOR IRON CONTENT
MANUFACTURER: Dercher Enterprises Inc., Darby, PA
RECALLED BY: Premier Medical Products, King of Prussia,
PA
DISTRIBUTION: CA, CT, IA, IL, IN, MD, ME, MI, MN, MO, ND,
NY, OH, PA, and WA
QUANTITY: 450 dozen
WEEK ENDING SEPTEMBER 8
PRODUCT AND CODE: MSM Eyes and Nasal Drops,
a liquid, packaged in white plastic 1 fluid oz eye drop bottles with a purple
and pink label. The product is labeled in part:"***MSM Eyes and Nasal
Drops***All That's Natural II***1 fl. oz.***Contains: Distilled water adjusted
to .09% Saline (from Sea Salt) and MSM, a fundametal source of nutritional
sulfur.***Suggested Use: Use as needed to relieve
irritated,
sore, or itchy eyes or nasal passages.***Distributed by: All That's Natural II,
Inc. 1-800-700-7477 www.atnmsm.com***"
The
product is an OTC eye and nasal drop containing methylsulfonylmethane. Codes:
All lots and codes
REASON: MICROBIAL CONTAMINATION (Pseudomonas
mendocina/Klebsiella pneumoniae).
MANUFACTURER/RECALLING FIRM: Allure Cosmetic, Inc.
Hayward, CA.
RECALLED BY: All That's Natural II, Inc. Gardena, CA
DISTRIBUTION: U.S. and Hawaii, Alaska, Puerto Rico,
American Samoa, and Washington, DC. AL,
AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MD, MN,
MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,
UT, VA, VT, WA, WI, WV, and WY.
QUANTITY: 44,000.
PRODUCT AND CODE: MSM Eyes Drops, 1 fl. oz.
The product is an OTC eye and nasal drop containing methylsulfonylmethane, MSM,
packaged under the brand name "UB Ultra Botanicals MSM Eye
Drops". The liquid is packaged in
white plastic 1 fluid oz eye drop bottles with a purple label. The product is labeled in part:"***UB
ULTRA BOTANICALS MSM EYE DROPS***1 FLUID OZ***Dosage: Two drops per eye daily.
Use more often for chronic conditions.***Contains: 5% MSM, (methylsulfonyl-methane) solution in
distilled water and .09% saline derived from Natural Sea Salt.***Exclusively
Manufactured For: ULTRA BOTANICALS, Inc. P.O. Box 2266. Los Angeles, CA
90064***". CODES: All codes and
lots.
REASON: MICROBIAL CONTAMINATION (Pseudomonas
mendocina/Klebsiella pneumoniae) MANUFACTURER/RECALLING
FIRM:
Allure
Cosmetic Inc. Hayward, CA.
RECALLED BY: Ultra Botanicals, Inc. Los Angeles, CA
DISTRIBUTION: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID,
IL, IN, KS, KY, LA, MA, ME, MI, MD, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY,
OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and Washington,
DC. Three bottles have been sold to a single consignee in Belgium.
QUANTITY: 18,026.
PRODUCT AND CODE: Tegretol® Tablets
(carbamazepine), 200 mg, LOT NOS 232E9126—bottles of 1,000 tablets
REASON: Dissolution failure.
MANUFACTURER/RECALLING FIRM: Novartis Pharmaceutical
Corp., Suffern, NY.
DISTRIBUTION: Nationwide
QUANTITY: 3,238 bottles.
PRODUCT AND CODE: Clonidine HCI, USP, in
bottles labaeled as containing 1, 5, or 25 grams per bottle. The bottles of drug are also labeled as
packaged by Universal Chemical, St. Peter, MN 56082.CODES: Lot UC99021002, packaged 02/99, CAS:
4205-90-7 and
Lot UC99021002A, CAS #4205-91-8.
REASON: Current Good Manufacturing Practice
Deviation-Production Records Do Not Correspond to Amounts of Product
Distributed.
MANUFACTURER
(bulk drug): Toning Limited Corporation Nanjing, China.
RECALLED BY: Hawkins Chemical Inc., Minneapolis, MN
DISTRIBUTION: Nationwide
QUANTITY: 75 1-gram bottles; 79 5-gram bottles, and 22 25 gram
bottles.
PRODUCT AND CODE: VANCERIL 42 MCG
(BECLOMETHASONE DIPROPIONATE) INHALATION AEROSOL, 16.8g -200 metered actuations
per canister.
CODES:
Lot
No. Expiration Date
1-AMA-202 FEB 2003
1-AMA-203 FEB 2003
1-AMA-204 FEB 2003
1-AMA-205 FEB 2003
REASON: POTENCY; Lack of assurance that canisters/product
can meet specifications (high or low)
MANUFACTURER/RECALLING FIRM: Schering Corp. Kenilworth,
NJ.
DISTRIBUTION: 44 states
nationwide.
QUANTITY: 322,644 canisters.
PRODUCT AND CODE: White with Blue
Specks. Caffeine tablets, 150 mg. The product is sold in 100 count and 500
count bottles. The label states
manufactured for: Pittsburgh Pill
Emporium, Pittsubrg, PA or Casey’s Distributors, Williamsport, PA. The Casey labeled product is only for the
100 count size. The Pittsburgh Pill
labeled product is for both the 100 and 500 count size. CODE: Lot #6076 exp. 2/02.
REASON: STABILITY:
There is no data to support labeled expiry date.
MANUFACTURER/RECALLING FIRM: Nittany Pharmaceuticals,
Inc., Milroy, PA.
DISTRIBUTION: PA.
QUANTITY: 142 bottles.
PRODUCT AND CODE: Overtime Stimulant
tablets, 200 mg caffeine, sold in 100 count and 500 count bottles. The label states that the product is distributed
by BDI Pharmaceuticals, A Division of Body Dynamics Inc., Carmel,
IN.CODES: Lot 6085 exp. 7/01 and Lot
10362 exp. 2/03.
REASON: STABILITY:
There is no data to support labeled expiry date.
MANUFACTURER/RECALLING FIRM: Nittany Pharmaceuticals,
Inc., Milroy, PA.
DISTRIBUTION: IN.
QUANTITY: 125 bottles.
PRODUCT AND CODE: Monsel Solution (Ferric
Subsulfate Solution), sold in an 8 ml vial in cases of 12 vials. CODE: Lot #57952 exp. 1/02.
REASON: Super-Potent for Iron Content.
MANUFACTURER/RECALLING FIRM: Dercher Enterprises, Inc.,
Upper Darby, PA.
RECALLED BY: Premier Medical Products, King of Prussia,
PA
DISTRIBUTION: CA, CT, IA, IL, IN, MD, ME, MI, MN, MO, ND,
NY, OH, PA, and WA.
QUANTITY: 450 dozen.
PRODUCT AND CODE: Vioxx 50 mg Tablets
(Rofecoxib Tablets), NDC 0006-01124-68, solid oral dosage form, packaged in
plastic bottles/plastic lid of 100.
CODE:
Lot
No. Exp.
Date
J9310 Nov-01
J9311 Nov-01
J9312 Nov-01
J9313 Nov-01
J9314 Nov-01
K2013 Aug-01
K2014 Aug-01
K2015 Mar-02
K2016 Mar-02
K2021 Mar-02
K2022 Mar-02
K2026 May-02
K2031 May-02
K2033 May-02
K2034 May-02
K2036 Mar-02
K2037 Nov-02
K2708 Nov-02
K2709 Nov-02
L3164 Nov-02
L3165 Nov-02
L3166 Nov-02
L3174 Nov-02
L3175 Jan-03
L3176 Jan-03
L3179 Jan-03
L3180 Jan-03
L3181 Jan-03
L3182 Feb-03
REASON: MISLABELING;
Product fails to declare container is a bulk package not intended for
dispensing and not child resistant.
MANUFACTURER/RECALLING FIRM: Merck Sharp & Dohme
Quimica de PR (Arecibo Pharmaceutical Operation), Arecibo, PR.
DISTRIBUTION: Nationwide.
QUANTITY: 622,427 units.
PRODUCT AND CODE: PTE-4, Pediatric, A
Mixture of Four Trace Elements Injection; for I.V. use only after dilution; a supplement
to intravenous solution given for TPN; 3 mL fill in 6.5 mL single dose vial;
American Pharmaceutical Partners, Inc., Los Angeles, CA 90024; product code
8203,NDC #63323-082-03. CODE: lot
number 100355, exp. 4-02.
REASON: Super-Potent for Chromium Ingredient (12 Month
Stability Testing).
MANUFACTURER/RECALLING FIRM: American Pharmaceutical
Partners, INC., Melrose Park, IL.
DISTRIBUTION: Nationwide and Canada.
QUANTITY: 78,925 vials.
PRODUCT AND CODE: Oxygen USP, Compressed,
The product is in 180 liter aluminum cylinder tanks. The product label states
"Oxygen USP***Produced by Air Liquefaction***Oxycare***120 Sibley
Ave***Ardmore, PA 19003" Codes: Lot # 06 25 011 exp. 1/06
REASON: Sub-Potent
MANUFACTURER/RECALLING FIRM: OxyCare, Inc. Ardmore, PA
DISTRIBUTION: PA and NJ
QUANTITY: 12 cylinders.
PRODUCT AND CODE: LITHOBID (Lithium
Carbonate, USP) Slow-Release Tablets Bottles of 100 tablets - The product
contains lithium carbonate, USP solid-release 300 mg. tablets. Expiration Date July 2001 Codes: Lot 90574, Expiration July 2001
REASON: Dissolution Failure
MANUFACTURER/RECALLING FIRM: Solvay Pharmaceuticals,
Inc. Baudette, MN.
RECALLED BY: Solvay Pharmaceuticals, Inc. Marietta, GA
DISTRIBUTION: Nationwide
QUANTITY: 14,480 units.
PRODUCT AND CODE: a) Good Sense brand
Children's Pain Reliever, acetaminophen suspension liquid, great tasting rich
cherry flavor, 4 fl oz (118 mL), 80mg per 1/2 teaspoon, OTC, Perrigo, Allegan,
MI
b)
Kroger brand Children's Pain Reliever, Acetaminophen Pain Reliever, Fever
Reducer, Suspension Liquid, Rich Cherry Flavor, 4 FL OZ
(118
mL), 80 mg per 1/2 teaspoon, OTC, Distributed by the Kroger Co., Cincinnati,
Ohio
c)
Hy-Vee brand Children's Non-Aspirin, Pain Relief Suspension Liquid,
Acetaminophen, Rich Cherry Flavor, 80 mg per 1/2 teaspoon
(160
mg per 5 ml), 4 FL OZ (118 mL), OTC, Distributed by Hy-Vee, Inc., West Des
Moines, IA Codes: a), b) and c) Lot #1AD0228
REASON: SUPER-POTENT (ACETAMINOPHEN)
MANUFACTURER/RECALLING FIRM: Perrigo Company Allegan, MI
DISTRIBUTION: United States
QUANTITY: a), b) and c) 7,788 units total
PRODUCT AND CODE: Tegretol® (Carbamazepine
USP) 200 mg tablets, in bottles of100 and 1000 tablets, Rx product
Initial
10 lots recalled on 9/18-11/27/00: 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).
First
extension (2/2001): 179D5121 (2/2003) - bottles of 100s 179D5216 (2/2003) -
bottles of 1000s
Second
Extension (8/9/01): Lot 232E9126 (exp. 3/2004) - bottles of 1000s
Third
Extension (9/6/01): Lot 205D6684 (9/2003) – bottles of 1000s Lot 206D6684
(9/2003) – bottles of 1000s
REASON: Dissolution Failure
MANUFACTURER/RECALLING FIRM: Novartis Pharmaceuticals,
Corp., Suffern, New York
DISTRIBUTION: Nationwide and Puerto Rico.
QUANTITY: Recall now covers a total of 15 lots. A total
of 172,586 bottles (150,223 bottles of 100s and 22,363 bottles of 1000s) for
the 10 initial lots of Tegretol® 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
First
Extension (2/5/01):
Lot
#179D5216: 2689 bottles of 1000s
Lot
#179D5121: 11,047 bottles of 1000s..
Second
Extension (8/9/01): Lot 232E9126: 3823 bottles.
***
Third Extension (9/6/01):Lot 205D6684: 3814 bottles. Lot 206D6684: 3752
bottles.
PRODUCT AND CODE: Temodar Capsules (Temozolomide)
250mg, 20 capsules per bottle,Lot Number 9-PHT-4, Exp. Date August 2002. Rx
only Each bottle packaged in an individual folding carton, for oral
administration, Rx only. Codes: Lot# 9-PHT-4 Exp. August 2002
REASON: UNDER FILLED CAPSULES
MANUFACTURER/RECALLING FIRM: University of Iowa - College
of Pharmacy, Iowa City, IA
RECALLED BY: Schering Corp. Kenilworth, NJ
DISTRIBUTION: Nationwide
QUANTITY: 738 bottles of
20 capsules
PRODUCT AND CODE: Premarin
Tablets,(Conjugated Estrogen Tablets USP) 1.25 mg. Bottles of 5,000. New Lot
numbers
Codes:
Lot 9010249, exp. Sept. 2003 Lot 9010403, exp. Sept. 2003
REASON: DISSOLUTION
FAILURE
MANUFACTURER/RECALLING FIRM: Ayerst
Laboratories Rouses Point, NY
RECALLED BY: Wyeth Ayerst
Pharmaceuticals Richmond, VA
DISTRIBUTION: AL, FL, NJ, NY,
OH, TN, and TX
QUANTITY: 2,070 bottles
PRODUCT AND CODE: TRAV-L-TABS
(Meclizine HCl) 25 mg per tablet, 60 tablets per bottle
Codes:
lots: 191002 Exp 9-01; 191111 Exp 10-01
REASON: PRODUCTION
VALIDATION DEVIATION (Extended Holding Times for Powdered Ingredients)
MANUFACTURER/RECALLING FIRM: Wendt
Laboratories, Inc., Belle Plaine, MN
DISTRIBUTION: ID, IL, NE, WI
QUANTITY: 770 bottles
WEEK ENDING SEPTEMBER 29
PRODUCT AND CODE: DIFLUCAN(R)(Fluconazole
Tablets), 100 mg., 30 tablet bottle, Rx only Codes: NDC 0049-3420-30
Lot
# EXP. DATE
04P015A AUG'02---RECALL
04P016A NOV'02---RECALL
94P029A JAN'02---RECALL
REASON: Counterfeit
MANUFACTURER/RECALLING FIRM: Unknown.
RECALLED BY: Kinray, Inc. Whitestone, NY
DISTRIBUTION: NY, NJ, PA, CT, MA, RI.
QUANTITY: 174 bottles.
PRODUCT AND CODE: All three products are
Breckenridge Pharmaceutical, Inc. brand, Dist. by: Breckenridge Pharmaceutical,
Inc., Boca Raton, FL. Manufactured by: ME Pharmaceuticals, Division of VESCO,
Inc., Richmond, IN.
a)
Ferocon Capsules, Hematinic Concentrate with Intrinsic Factor, Rx, 100 unit
dose capsules per carton (10 capsule blister card, 10 cards per
carton).
b) Vinatal Forte, Prenatal Vitamin Tablet with Iron, Rx, 90 unit dose tablets
(10 tablet blister card, 9 cards per carton).
c)
Vinate Advanced, Prenatal Vitamin and Mineral Supplement, Rx, 90 unit dose
tablets (10 tablet blister card, 9 cards per carton).
CODES:
all lots with expiration date of 1/2003 and prior
REASON: Subpotent for Folic Acid.
MANUFACTURER/RECALLING FIRM: M.E. Pharmaceuticals, Inc.
Economy, IN.
DISTRIBUTION: TN
QUANTITY: a) 1,324,800 capsules; b) 980,640 tablets; c)
500,000 tablets.
PRODUCT AND CODE: Diphenhist CAPTABS, Antihistamine,
(Diphenhydramine HCl) USP, 25 mg, Rugby Brand,100 count bottles.
Codes:
Product # 003-5970.
Lot
# Expiration Date
00C035 03/2002
00J019 09/2002
00K002 10/2002
01A036 01/2003
01C023 03/2003
01E014 05/2003
01F034 06/2003
REASON: Misbranding: Carton labeling incorrectly lists
inactive ingredients including but not limited to – color additives.
MANUFACTURER/RECALLING FIRM: Advance Pharmaceutical,
Inc. Ronkonkoma, NY.
DISTRIBUTION: GA.
QUANTITY: 22,866 bottles (100s).
PRODUCT AND CODE: Pulmolite, Kit for the
preparation of Technetium Tc99m Albumin Aggregated for Injection
Sterile
and non-pyrogenic Lot 127254; Exp. Date: 01 AUG 02 For Diagnostic Use Rx Only
NDA 17-776
Codes:
Pulmolite, Lot 127254. Exp. Date: 01 AUG 02
REASON: Lack of assurance of sterility (Crimp seal
problems)
MANUFACTURER/RECALLING FIRM: Ben Venue Laboratories,
Inc. Bedford, OH.
RECALLED BY: CIS-US, Inc. Bedford, MA
DISTRIBUTION: Nationwide.
QUANTITY: 33,475 vials packaged in 5 vial kits and 30 vial
kits.
Greenstone
brand Glyburide Tablets, 1.25 mg, bottle of 100 Lot number: 37DYR, 84DTF
Greenstone
brand Glyburide Tablets, 2.25 mg, bottle of 100 Lot number: 40FCW, 42FCW.
44FCW, 46FCW, 76DWD, 88DTF
Greenstone
brand Glyburide Tablets, 5 mg, bottle of 100 Lot number: 18FTH, 19FTH, 18FTD,
39FTD, 17FTH, 93FRY, 95FRY, 96FRY, 57FJD, 58FJD, 14FJX, 75FKR, 74FKR, 44FMD,
60FJD
Greenstone
brand Glyburide Tablets, 5 mg, bottle of 500 Lot number: 43FKW, 85FMU, 86FMH
Greenstone
brand Glyburide Tablets, 5 mg, bottle of 1000 Lot number: 12FTH, 61FJD, 11FMF,
59FMD, 15FJX, 17FJX, 18FKS, 16FKS, 15FKS, 22FKS, 19FKS, 07FMF, 10FMF, 28FMK,
02FJX, 17FKS
Greenstone
Limited is recalling the above-mentioned products. An investigation has
detected the presence of fungal organisms in some lots. If you have any
questions regarding this recall, please call 1-800-323-4204, 8:00 am to 5:00 pm
EST.