SEPTEMBER 2005
WEEK ENDING SEPTEMBER 3
PRODUCT Albuterol Sulfate
Inhalation Solution, 0.083% (2.5mg/3mL), 60 x 3 mL Sterile Unit Dose Vials, Rx
Only, For Oral Inhalation Use Only.
CODE Lot #
W12241 and W12242
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAX
Pharmaceuticals, Miami, FL
Manufacturer:
IVAX Pharmaceuticals U.K. Ltd, Preston Brook, Runcorn Cheshire WA7 3FA, UK.
REASON
Discoloration
VOLUME OF
PRODUCT IN COMMERCE 3,540 cartons (60 x 3mL Unit Dose Vials per
carton)
DISTRIBUTION Nationwide
PRODUCT Anagrelide Hydrochloride
Capsules, 0.5 mg (base), 100 tablet bottles, Platelet-Reducing Agent, Rx only.
CODE
Lot 358001V, expiration date Jun
06
RECALLING FIRM/MANUFACTURER Boehringer Ingelheim Roxane, Inc,
Columbus, OH
REASON Dissolution Failure
VOLUME OF PRODUCT IN
COMMERCE 6,180/100 tablet
bottles
DISTRIBUTION Nationwide
PRODUCT MINOXIDIL Tablets, USP,
2.5 mg, 100-tablet bottles, Rx only, NDC # 0591-5642-01
CODE Lot L5A0061, Expiration date
01/31/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Watson
Pharmaceuticals, Inc., Corona, CA,
Manufacturer: Watson Laboratories, Inc., Carmel, NY.
REASON
Oversized tablets
VOLUME OF PRODUCT
IN COMMERCE 7,685 bottles x 100
bottles
DISTRIBUTION Nationwide
PRODUCT Adenoscan Adenosine
Injection, 3 mg/mL in a 30 mL single dose vial, 10 vials per shelf tray, 10
trays per case; an Rx injectable drug for intravenous infusion only, product
code 87130, NDC # 0469-0871-30,
CODE Lot
20-251-DK, Expiration date 8/2008
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Astellas Pharma US Inc., Deerfield, IL,
Manufacturer: Hospira Inc., Rocky Mount,
NC.
REASON There has been an
increase in adverse events reported for this lot of Adenoscan.
VOLUME OF
PRODUCT IN COMMERCE 137,340 vials
DISTRIBUTION Nationwide,
PR, Guam, and Canada
PRODUCT Hemocyte Tablets
(Ferrous Fumarate 324 mg) Folic Acid 1 mg US Pharmaceutical Corporation-Decatur,
GA 300235 USA * Distributors. Container/closure system is film and foil blister
package. Blisters are inserted into 0.16 sold bleach sulfate cardboard cartons.
Product is packed: 100's: 10 blister cards x 10 tablets; 30's: 3 blister cards x
10 tablets, UPC Codes: 100's: 52747307701101, 30's: 52747307301101
CODE
Lot number: 050520-01, Expiration date:
05/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: U S
Pharmaceutical Corporation, Decatur, GA
Manufacturer: Opti-med Controlled Release Labs, Seymour, IN.
REASON
Mislabeling: The blister cards
are printed with "Folic Acid 1 mg" as an ingredient, which in not in the
Hemocyte Tablets.
VOLUME OF PRODUCT IN COMMERCE 7,391
cartons
DISTRIBUTION Nationwide
PRODUCT Fougera Nystatin and
Triamcinolone Acetonide Cream USP, Each gram contains 100,000 USP Nystain Units
and l mg triamcinolone acetonide, Net Wt. 30 grams, Rx only, NDC # 0168-0081-30,
CODE
Lot M303, Expiration date
8/05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Altana Inc.,
Melville, NY
Manufacturer: Altana Inc.,
Hicksville, NY.
REASON Subpotent:
Triamcinolone Acetonide (21 month stability).
VOLUME OF PRODUCT IN
COMMERCE 64,662 tubes
DISTRIBUTION Nationwide
PRODUCT Zovia 1/35E-28 Tablets
USP (Ethynodiol Diacetate and Ethinyl Estradiol), cartons of 6 tablet
dispensers, 28 tablets each, Rx only,
CODE Lot
#38303H04
RECALLING FIRM/MANUFACTURER Watson Laboratories, Corona, CA
REASON
There was an out-of-specification result for total
impurities at the 12-month stability test point.
VOLUME OF PRODUCT IN
COMMERCE 14,880 cartons
DISTRIBUTION Nationwide
PRODUCT Rite Aid brand Acid
Reducer Tablets (Ranitidine USP), 75 mg, 75 tablets, 75 Doses, Made in India,
CODE
Lot # 4MB0447
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Leiner Health Products Llc, Carson,
CA
Manufacturer: Dr. Reddy's Laboratories, Hyderabad, India.
REASON
Mispacked; Lot was packaged without a
desiccant.
VOLUME OF PRODUCT IN COMMERCE 22,188
bottles
DISTRIBUTION Nationwide
WEEK ENDING SEPTEMBER 10
PRODUCT Nature Throid NT-1,
Thyroid, U.S.P. (TAN, C.T.), 1 Grain (64-8 MG), 100 Tablets
CODE Lot # M012Q-5D11
RECALLING
FIRM/MANUFACTURER
Recalling Firm: RSJ Inc, Phoenix, AZ,
Manufacturer: Time-Cap
Labs, Farmingdale, NY.
REASON Mislabeled; bottles labeled to contain
Nature-Throid NT-1 actually contain Nature-Throid NT-1/2.
VOLUME OF
PRODUCT IN COMMERCE 94 Bottles
DISTRIBUTION Nationwide
PRODUCT
a) Pain Reliever -
Infant Drops, Acetaminophen 160 mg per 1.6 ml ˝ fl oz (15 mL), Cherry
Flavor, Use Only With Enclosed Syringe. Directions: Weight under 24 lb or
Age Under 2 years - ask a doctor. Product is distributed under the
following brand names: Best Choice brand Infants' Non-Aspirin, by Valu
Merchandisers; Brooks brand Infants' Acetaminophen Concentrated Suspension Drops, Dist. by Maxi Drug Inc.; CVS brand Concentrated
Infants' Pain
Relief Suspension Drops, Dist. by CVS Pharmacy, Inc.; Eckerxd brand
Non-Aspirin Infant's Drops, Dist. by Eckerd Drug Company, NDC 19458-9081-1; equaline brand Infants' Pain Relief Concentrated
Suspension Drops, Dist.
by Albertsons, Inc., NDC 41163-008-05; Food Lion brand Infant's Drops Pain
Relief Concentrated Suspension Drops, Dist. by Food Lion, LLC, NDC
55316-008-10; Good Neighbor Pharmacy brand Concentrated Pain Relief Infants'
Drops, Dist. by AmerisourceBergen, NDC 24385-313-15; GoodSense brand Infants' Pain Relief Concentrated Suspension Drops,
Dist. by Perrigo
Company, NDC 0113-0008-10; Healthy Generations brand Infants' Drops
Non-Aspirin Pain Relief, Dist. by Supervalu, Inc., NDC 38045-008-05; H-E-B brand Infants' Pain Relief Infants' Concentrated
Suspension Drops,
Dist. by H-E-B, NDC 37808-008-10; HyVee brand Concentrated Pain Relief
Infants' Drops,
Dist. by Hy-Vee, Inc., NDC 42507-008-10; Kroger brand Infant's Pain Relief Concentrated Suspension Drops,
Dist. by The Kroger
Co., NDC 30142-008-05; Leader brand Infants' Drops Pain Reliever
Concentrated Suspension Drops, Dist. by Cardinal Health, NDC 37205-008-05; Longs brand Infants' Pain Relief, Dist. by Longs Drugs,
NDC
12333-9749-1; Major brand Infants' Mapap Concentrated Suspension Drops,
Dist. by Major Pharmaceuticals, NDC 0904-5255-35; Medic brand Infants' Acetaminophen Pain Reliever Infants' Concentrated
Suspension Drops,
Dist. by Winn-Dixie Stores, Inc., NDC 56039-008-05; The Medicine Shoppe brand
Infants' Drops Medi-Tabs Concentrated Suspension Drops, Dist. by Medicine
Shoppe International, Inc., NDC 49614-313-10; Meijer brand Infant's Pain
Relief Concentrated Suspension Drops, Dist. by Meijer Dist. Inc., NDC
41250-008-10; Publix brand Pin Relief Concentrated Infants' Drops, Dist. by
Publix Super Markets, Inc., NDC 56062-008-05; Rite Aid brand Infants' Pain
Relief Concentrated Suspension Drops, Dist. by Rite Aid Corp.; Safeway
brand Infants' Non-Aspirin Concentrated Suspension Drops, Dist. by Safeway
Inc., NDC 21130-008-05; Sunmark brand Pain Reliever Infants' Concentrated Suspension Drops, Dist. by McKesson,
NDC 49348-268-27;
Target brand Infants' Drops Acetaminophen Concentrated, Dist. by Target
Corp.; NDC 11673-008-10; Today's Health brand Infants' Pain Reliever
Concentrated Suspension Drops, Dist. by Warehouse Concepts, Inc., NDC
38309-008-05; Walgreens
brand Infant's Non-Aspirin Infants' Concentrated Suspension Drops, Dist. by Walgreen Co., NDC 0363-008-10
and Western
Family brand Infant's Acetaminophen Concentrated Suspension Drops, Dist. by
Western Family Foods, Inc.,
b) Pain Reliever - Infant
Drops, Acetaminophen 160 mg per 1.6 ml ˝ fl oz (15 mL), Grape Flavor, Use
Only WithEnclosed Syringe, Directions: Weight under 24 lb or Age Under
2 years - ask a doctor. Product is distributed under the following brand
names: American Fare brand Infants' Pain Relief Infants' Concentrated
Suspension Drops, Made for Kmart Corporation, NDC 49738-289-10; Berkley
& Jensen brand Infant's Pain Relief, Distributed by BJWC; Brooks brand
Infants' Acetaminophen Concentrated Suspension Drops, Dist. by Maxi Drug
Inc.; Carxe One brand Infant's Pain Relief Concentrated Suspension
Drops, Dist. by American Sales Co.; CVS brand Concentrated Infants' Pain
Relief Suspension Drops, Dist. by CVS Pharmacy, Inc.; DG Guarantee brand Infants' Pain Relief Concentrated Suspension Drops,
Dist. by Dolgencorp
Inc.; Eckerxd Pharmacy brand Non-Aspirin Infant's Drops, Dist. by Eckerd
Drug Company, NDC 19458-9082-1; equaline brand Infants' Pain Relief concentrated suspension drops, Dist. by
Albertsons, Inc., NDC
41163-289-05; equate brand Infants' Drops Pain Reliever, Dist. by Wal-Mart
Stores, Inc., NDC 49035-289-05; Family Dollar brand Infants' Pain Reliever, Dist. by Family Dollar Services Inc.,NDC 55319-289-05; Good
Neighbor Pharmacy brand Concentrated Pain Relief Infants' Drops, Dist. by Amerisource Bergen, NDC 24385-289-10; GoodSense brand
Infants' Pain
Relief Concentrated Suspension Drops, Dist. by Perrigo Company, NDC
0113-0289-05; Health Pride brand Infants' Pain Reliever, Dist. by The Great Atlantic & Pacific Tea Company; H-E-B brand
Infants' Pain
Relief Infants' Concentrated Suspension Drops, Dist. by H-E-B, NDC
37808-289-05; Healthy Generations brand Infants' Drops Non-Aspirin Pain Relief, Dist. by Supervalu, Inc., NDC 38045-289-05;
Kroger brand
Infant's Pain Relief Concentrated Suspension Drops, Dist. by The Kroger Co.,
NDC 30142-289-05; Leader brand Infants' Drops Pain Reliever Concentrated
Suspension Drops, Dist. by Cardinal Health, NDC 37205-319-05; Medic brand
Infants' acetaminophen Pain Reliever Infants' Concentrated Suspension
Drops, Dist. by Winn-Dixie Stores, Inc., NDC 56039-289-05; Rite Aid brand
Infants' Acetaminophen Pain Relief Concentrated Suspension Drops, Dist. by Rite Aid Corporation; Shop Rite brand Infants'
Concentrated
Pain-Relief Infants' Suspension Drops, Dist. by Wakefern Food Corp.; Sunmark
brand Pain Reliever Infants' Concentrated Suspension Drops, Dist. by
McKesson, NDC 49348-267-29; Target brand Infants' Drops Acetaminophen
Concentrated, Dist. by Target Corp., NDC 11673-289-10; Today's Health brand
Infants' Pain Reliever, Dist. by Warehouse Concepts, Inc., West NDA
38309-289-05; Top Care brand Infants' Pain Reliever Concentrated Suspension
Drops, Dist. by Topco Associates, LLC, NDC 36800-289-10; Walgreens brand Infants' Non-Aspirin Infants' Concentrated Suspension
Drops, Dist. by
Walgreen Co., NDC 0363-0289-05 and Western Family brand Infant's
concentrated Suspension Drops, Dist. by Western Family Foods, Inc.,
c) Cough & Cold Concentrate Infant Drops,
Acetaminophen 160 mg per 1.6 ml, Dextromethorphan BBr 5 mg per 1.6 ml,Pseudoephedrine HCl 15 mg per 1.6 ml; ˝ fl oz (15
mL), Cherry Flavor,
Use Only With Enclosed Syringe, Directions: Weight under 24 lb or Age Under
2 years --ask a doctor. Product is distributed under the following brand
names: American Fare brand Infants' Pain Relief Cold Concentrated Infants'
Drops Cold plus Cough, Distributed by Kmart Corporation, NDC 49738-514-05;
DG Guarantee brand Infants' Drops Pain Relief Plus Cold & Cough,
Distributed by Dolgencorp Inc.; Equaline brand Infants' Drops Pain Relief
plus Cold & Cough, Distributed by Albertsons, Inc., NDC 41163-514-05; Family Dollar brand Infants' Concentrated Cold & Cough,
Distributed
by Family Dollar Services Inc., NDC 55319-514-05; Healthy Generations brand
Infants' Cold & Cold, Distributed by Supervalu, Inc., NDC 38045-514-05; Kroger brand Infants; Pain Relief plus Cold & Cough
Concentrated
Drops, Distributed by The Kroger Co., NDC 30142-514-05; Leader brand
Infants' Pain Relief Cold plus Cough Concentrated Drops, Distributed by
Cardinal Health, NDC 37205-293-05; The Medicine Shoppe brand Infants;
Concentrated Medi-Drops Cold & Cough, Distributed by Medicine Shoppe,
NDC 49614-122-05; Rite Aid brand Infants' Cold & Cough Concentrated
Drops,
Distributed by Rite Aid Corp,; Top Care brand Infants; Drops Cold
plus Cough Concentrated, Distributed by Topco Associates, LLC, NDC
36800-514-05 and Walgreens brand Concentrated Non-Aspirin Plus Cold &
Cough Infants' Drops, Distributed by Walgreen Co., NDC 0363-0514-05.
d)
Decongestant & Cough Infant Drops,
Dextromethorphan BBr 5 mg per 1.6 ml, Pseudoephedrine HCl 15 mg per 1.6 ml; ˝ fl oz (15
mL), Cherry Flavor, Use Only With Enclosed Syringe,
Directions: Age Under 2 years - ask a doctor. Product is distributed under
the following brand names: CVS brand Infants' Decongestant & Cough,
Dist. by CVS Pharmacy, Inc.; equaline brand Infants' Decongestant &
Cough Oral Drops, Dist. by
Albertsons, Inc., NDC 41163-487-05; GoodSense
brand Infants Decongestant & Cough Oral Drops, Dist. by
Perrigo Co.,
NDC 0113-0487-05; Healthy Generations brand Infants' Cough & Cold, Dist.
by Supervalu, Inc., NDC 38045-487-05; Longs brand Infants' Decongestant
& Cough, Dist. by Longs Drugs, NDC 12333-9870-1; Major brand
Infants' Drops Decongestant and Cough, Dist. by Major Pharm., NDC
0904-5552-35; Meijer brand Infants' Decongestant & Cough Oral Drops,
Dist. by Meijer Dist Inc., NDC 41250-487-05; Publix brand Infants' Drops Decongestant Plus Cough, Dist. by Publix Super Markets,
Inc., NDC
56062-487-05; Rite Aid brand Pedia Relief Decongestant plus Cough Drops for
Infants, Dist. by Rite Aid Corp.; Sunmark brand Infants' Drops Pedia Relief Decongestant Plus Cough, Dist. by McKesson, NDC 49348-290-69; Top Care
brand Pediatric Nasal Decongestant Plus Cough Infants' Drops, Dist. by Topco
Ass., LLC, NDC 36800-487-05 and Walgreens brand Infants' Wal-Care Decongestant Plus Cough, Dist. by Walgreen Co., NDC
0363-0487-05.
CODE All lots with a syringe for dosing
RECALLING
FIRM/MANUFACTURER Perrigo Company, Allegan, MI,
REASON Although the labeled directions for use are
consistent with the labeled dosage directions; the product is also intended for
use by infants under 2 years of age, and the dosing syringe included with the
product is not appropriate for the dosage levels generally directed by doctors
for infants under 2 years of age.
VOLUME OF PRODUCT IN
COMMERCE 1,072,098 bottles
DISTRIBUTION Nationwide
WEEK ENDING SEPTEMBER 17
PRODUCT Zomig ZMT (Zolmitritan)
5 mg tablets. The product is sold as a three tablet blister card with one card
per carton, Rx only
CODE Lot number KN0086 exp
4/30/06
RECALLING FIRM/MANUFACTURER
Recalling Firm:
AstraZeneca Pharmaceuticals, LP, Newark, DE
Manufacturer: Cima Laboratories, Inc., Eden Prairie, MN.
REASON
Short Fill; Complaints of
empty blister packs.
VOLUME OF PRODUCT IN COMMERCE 86,544
cartons
DISTRIBUTION Nationwide
PRODUCT Prednisolone Sodium
Phosphate Oral Solution (prednisolone sodium phosphate, USP) * 6.7 mg/5 mL
(equivalent to 5 mg prednisolone base) * 5 mL unit dose and 120 mL bottles*
non-alcoholic, dye free, sugar free * Rx Only * * NDC 0121-0711-04 * NSN
6505-01-268-3713 *,
CODE NDC 0121-0711-05, Lot:
4F07, 4J47 & 5B08 (5mL Unit Dose); NDC 0121-0711-04, Lot: 4F06, 4J48 &
5B07 (120 mL bottle); NDC 59196-011-04, Lot: 4H50 (120 mL
bottle)
RECALLING FIRM/MANUFACTURER Pharmaceutical Associates,
Inc., Greenville, SC
REASON Impurity; the product exceeds the specification for
impurity.
VOLUME OF PRODUCT IN COMMERCE 46,411
units
DISTRIBUTION Nationwide
Injectable Products made by Central Admixture Pharmacy Service (CAPS) of Lanham, Maryland
Central Admixture Pharmacy Service
(CAPS) of Lanham, Maryland is recalling all injectable products due to concerns regarding
the sterility of these injectable products. CAPS distributed the affected
injectable products to hospitals in Maryland, Delaware, Washington, D.C.,
and Virginia. Gram negative rods have been identified in two lots of
Cardioplegia solution manufactured by CAPS. Non-sterility of injectable
products could represent a serious hazard to health that could lead to
life-threatening injuries and death.
The following products distributed up to September 16, 2005, are affected by
this action:
Although CAPS has directly notified known hospital customers of the recall, hospitals, physicians, and health care workers are urged to examine their supplies for any CAPS of Lanham, MD injectable products and immediately discontinue their use and quarantine the products.
PRODUCT
a) The Boy's Farmer
Market Smoked Nova Salmon, packed in a one pound (1 lb) vacuum pack plastic
bag,
b) Marshall's Naturally Smoked Nova Salmon, packed in a one pound (1 lb) vacuum pack plastic bag,
c)
SeaSpecialties Sliced Smoked Salmon,
d) Naturally
Smoked Homarus Norwegian Salmon packaged in a 4 oz. vacuum packaged bag,
e) Marshall's Naturally Smoked Nova Salmon New York Style,
packaged in a 4 oz vacuum packaged plastic bag,
f)
Smoked Salmon Shreds packaged in 10 lb. plastic buckets and 5 lb. plastic
bags.
CODE
a) Batch # 31997, sell by
4/25/05;
b) and c) Batch # 31997;
d) Batch # 31973;
e) Batch #
32123;
f) Batch # 31980
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Florida Smoked Fish Certified, Miami, FL,
Manufacturer: Sea Specialties, Miami, FL.
REASON
Smoked Salmon is contaminated with Listeria
Monocytogenes based on the Florida Department of Agriculture and Consumer
Services' analysis.
VOLUME OF PRODUCT IN COMMERCE 1,386
lbs.
DISTRIBUTION FL
WEEK
ENDING SEPTEMBER 30
PRODUCT Furosemide, 40mg, 1000
count bottles (packaged in white HDPE bottles), Rx only, NDC #0591-3437-10,
CODE
Lot # T053L04A, expiry 12/06
RECALLING
FIRM/MANUFACTURER Vintage Pharmaceuticals LLC, Huntsville, AL
REASON
Mold
Growth was found on tablets.
VOLUME OF PRODUCT IN COMMERCE 2,574
bottles of 1000
DISTRIBUTION CA
PRODUCT
a) Zonegran® (zonisamide) capsules, 25mg, 100 capsules,
Rx only, EGC White Op./White Op
Size 4, Black
lettering "e" and "Zonegran 25",
b) Zonegran® (zonisamide) capsules, 50mg, 100 capsules,
Rx only, EGC White
Op./Grey Op Size 3, Black
lettering "e" and "Zonegran 50",
CODE
a) Lot number: 34940 & 34941;
b) Lot number:
34943 & 34944
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Eisai Inc, Research Triangle Park, NC
Manufacturer: Elan Pharma Ltd.,
Westmeath, Ireland.
REASON Adulteration: Presence of foreign
capsules.
VOLUME OF PRODUCT IN COMMERCE 7,949
units
DISTRIBUTION Nationwide
PRODUCT Fluorouracil Injection,
USP, 50 mg/mL in 10 mL single dose vials, 10 vials per shelf tray, 10 trays per
case; Rx only, Sterile, For IV Use, product code 101710, NDC 63323-117-10,
CODE
Initially lot 141481, exp. 06/06 was recalled
on 9/8/05. The recall was expanded to include the following lots by letter dated
9/19/05: lot 140493, exp 11/05; lot 140683, exp 12/05; lot 140684, exp 12/05;
lot 140943, exp 2/06; lot 140944, exp 2/06; lot 141057, exp 3/06; lot 141058,
exp 3/06; lot 141192, exp 4/06; lot 141193, exp 4/06; lot 141328, exp 5/06; lot
141329, exp 5/06; lot 141438, exp 5/06; lot 141349, exp 5/06; lot 141452, exp
6/06; lot 141482, exp 6/06; lot 200117, exp 7/06; lot 200123, exp 7/06; lot
200124, exp 7/06; lot 200143, exp 8/06; lot 200144, exp 8/06; lot 200175, exp
8/06; lot 200176, exp 8/06; lot 200364, exp 9/06; lot 200383, exp 10/06; lot
200384, exp 10/06; lot 200463, exp 10/06; lot 200466, exp 10/06; lot 200467, exp
10/06; lot 200500, exp 11/06
RECALLING FIRM/MANUFACTURER American
Pharmaceutical Partners, Inc., Melrose Park, ILg.
REASON Presence of particulate matter: The product may
contain glass particles.
VOLUME OF PRODUCT IN COMMERCE 1,454,080
vials
DISTRIBUTION Nationwide including Puerto Rico
PRODUCT
Genteal Gel Severe
Lubricant Eye Gel. Hypromellose, 0.3%, lubricant. Relieves dryness of the eye.
Preservative Free in the Eye, Made in Puerto Rico. NDC 58768-790-36,
CODE
Lot Z13322 Exp 8/2006
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Novartis Pharmaceuticals Corp,
East Hanover, NJ
Manufacturer:
Cardinal Health Manufacturing Services B.V., Humacao, PR. .
REASON Defective container: Possibility of tubes
leaking.
VOLUME OF PRODUCT IN COMMERCE 13,056
tubes
DISTRIBUTION Nationwide
PRODUCT Premarin (conjugated
estrogens) tablets, USP, 0.9 mg, 100 tablet bottles, Rx, NDC 0046-0864-81,
CODE
Lot A67610, Exp. 07/2006
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Richmond Division of Wyeth,
Richmond, VA,
Manufacturer: Wyeth
Pharmaceuticals, Rouses Point, NY.
REASON Dissolution Failure: Fails to conform to USP
dissolution specifications.
VOLUME OF PRODUCT IN COMMERCE 98,260
bottles
DISTRIBUTION Nationwide