APRIL 2007
WEEK ENDING APRIL 7
PRODUCT Cardioplegia
infusion solutions including the following product names: Cold Induction,
Cardiac Reperfusate, Physiologic K Warm Induction, Low K Maintenance, Warm
Induction, High K Cold Induction, Regular Maintenance, Enriched Reperfusate,
Regular Induction, Cardioplegic Solution Bag #1, Cardioplegic Solution Bag #2,
Cardioplegic Solution Bag #3, Cardioplegic Solution Bag #4, Cardioplegic
Solution Bag #5, Cardioplegia Solution ''A'', Cardioplegia Solution ''B'',
Cardioplegic Solution ''C'', Multidose Cardioplegia, Cardioplegia Bag #1,
Cardioplegia Bag #2, Cardioplegia Bag #3, Hot Shot Cardioplegia, Dr. Johnson Low
K Formula, Dr. Johnson High K Formula, Bag #1, Bag #2, Modified Buckberg Cold
Induction, Modified Buckberg Maintenance, Modified Buckberg Reperfusion, Cardio
Base #2, Fairfax REPF, Fairfax BASE, Cardio Enriched Solution, Cardio Base #1,
Theodoro Cardioplegia Solution, Warm Induction, Multidose VC Standard, Induction
and Reperfusion Formulation, AAECS Bag #1, NONAAECS Comp. Soln., Hot Shot,
Maintenance, Reperfusion, Maintenance Multidose Cardioplegia, Cardioplegia
Solution ''D'', Induction Formula, Maintenance Formula, Enriched Induction
Cardioplegia, Buckberg Cardioplegia V, Buckberg Cardioplegia VI, Reperusate
''Hot Shot'' Cardioplegia, Cardiolegia Low K, Cardioplegia High K, Low Potassium
Cardioplegia, High Potassium Cardioplegia, Cardio Base One (1) High K, Cardio
Base Two (2) Low K, Enriched Cardioplegia Solution, Maintenance Cardioplegia,
Induction Cardioplegia, Union Memorial Cold Induction, Union Memorial
Maintenance. Products are manufactured to order and packaged in clear plastic
infusion bags in various volumes, and labeled in part '***Prep by: Central
Admixture Pharmacy services, Inc. Birmingham***'. The product is labeled with
the names (as listed above), the component formula and the specified consignee
CODE
None. Sold by prescription
only.
RECALLING FIRM/MANUFACTURER Central Admixture Pharmacy
Services Inc., Homewood, AL
REASON Mislabeled; Cardiac infusion drug may contain 5%
Dextrose in water instead of Citrate Phosphate Dextrose.
VOLUME OF PRODUCT
IN COMMERCE 1,791 bags
DISTRIBUTION AL, FL, TN, LA, VA, MS,
KS, MO. MD, GA, and D.C
Ortho-McNeil Pharmaceutical, Inc. Issues a Recall of
Grifulvin V®/Griseofulvin Oral Suspension
Glass bottles of griseofulvin oral suspension (liquid) [GRIFULVIN V®], microsize 125 mg/5mL, a prescription medicine used to treat ringworm and other fungal infections, are being recalled as a precaution from wholesalers and retail pharmacies nationwide. The recall is a precaution based on reports of glass fragments found in bottles of the liquid formulation. Consumers who believe they are in possession of recalled product should contact the pharmacy where the medicine was purchased.
This recall is limited to the liquid formulation of the medication and does not include any other dosage form.
The lots were shipped to distributors in the United States only between August 23, 2005 and March 14, 2007. Lot numbers are posted on www.aboutgrifulvin.com. Lot numbers can be found on the back of the product label only on four-ounce (120 mL) glass bottles filled by the manufacturer. Consumers with pharmacy-dispensed bottles, which were filled at the pharmacy and do not contain lot numbers, should contact the pharmacy where they purchased the medicine to determine if they are in possession of product that has been recalled.
In addition to contacting the pharmacy where the medicine was purchased, consumers who believe they are in possession of recalled bottles of GRIFULVIN V® griseofulvin oral suspension (liquid) may also call 1-800-426-7762. Consumers who believe they are in possession of affected product from Patriot Pharmaceuticals, LLC, griseofulvin oral suspension (liquid), may call 1-800-510-0383. Consumers should direct medical questions to their health care providers. Adverse reactions experienced with the use of this product should be reported to the company using the telephone numbers above.
PRODUCT
a) Coricidin "D",
(acetaminophen 325 mg with Phenylephrine HCl 5 mg
and Chlorpheniramine
Maleate 2 mg), 24 Film-Coated Tablets,
b) CVS
Pharmacy brand Sinus Pain & Congestion Nighttime,
(acetaminophen 325 mg,
Phenylephrine HCl 5 mg and Chlorpheniramine
Maleate 2 mg), 24 Caplets, (SKU
# 405565/UPC# 50428102640) ----
Also labeled under other brand name as
follows; QC-Quality Choice
brand Multi-Symptom Allergy Relief, (SKU
#QC95611/UPC# 635515956117),
CODE
a) Lot
numbers: (Coricidin ''D'') 6D01WN, 6E01WN, 6E02AWN, 6E02WN,
6G02WN, 6H01WN,
6H02WN, 6K01WN, 6K02WN, 6K03WN;
b) (CVS): 6NB0698 and (QC):
6NB0369
RECALLING FIRM/MANUFACTURER Leiner Health Products LLC,
Carson, CA,
REASON Stability data does not support expiration
date.
VOLUME OF PRODUCT IN COMMERCE 117,316.8 units (24 caplets
per)
DISTRIBUTION MI, RI, TN
PRODUCT Differin (adapalene)
Cream, 0.1%; Rx Only; NDC 0299-5915-45,
CODE Lot #045193
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Galderma Laboratories, Inc.,
Fort Worth, TX,
Manufacturer: Galderma
Production Canada, Inc., Baie-D Quebec, Canada. REASON Mispacked. Shipping containers labeled as Differin Cream
actually contains Differen Gel.
VOLUME OF PRODUCT IN
COMMERCE 40,056 tubes (1669 shipping
containers)
DISTRIBUTION Nationwide and Jamaica
PRODUCT Severe Cold PE
Caplets (OTC), Acetaminophen 325 mg, Phenylephrine HCl 5 mg and Diphenhydramine
HCl 12.5 mg caplets. The bulk lot was subsequently packaged under the Target
label. Target UPC #: 074990747818,
CODE Lot #:
6FE9056
RECALLING FIRM/MANUFACTURER
Recalling Firm: Leiner
Health Products LLC, Carson, CA,
Manufacturer: Amneal Pharmaceuticals,
LLC., Paterson, NJ.
REASON Failed Content Uniformity
Requirements.
VOLUME OF PRODUCT IN COMMERCE 15,744 bottles (24
caplets per bottle)
DISTRIBUTION MN
PRODUCT Pharmacist Formula
Women's Gentle Laxative Tablets (Bisacodyl) 5 mg, blister packs of 30 and 90,
Enteric Coated, Stimulant Laxative, Manufactured By Leiner Health Products, ----
Also labeled under other brands as follows; Dollar General brand Women's
Laxative Tablets, Distributed by: Dolgencorp, Inc., Eckerd brand Stimulant
Laxative women's laxative, Eckerd Corporation, d/b/a Eckerd Pharmacy, Family
Dollar brand Laxative, Distribution by Family Dollar Services, Inc., Marc's
Central Warehouse, Golub Corporation, CDMA, SAJ Distributors, Target
Corporation, and Wegmans Gentle Laxative, Distributed by Wegmans Food Markets,
Select Brand Women's Gentle Laxative, Distributed by Select Brand Distributors,
Price Chopper brand Laxative Tablets,
CODE Bulk
Code BA0026AA, All packaging lots.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Leiner Health Products
LLC,
Carson, CA,
Manufacturer: Time-Cap Labs,
Farmingdale, NY.
REASON Stability
data does not support expiration date.
VOLUME OF PRODUCT IN
COMMERCE\ 408,960 tablets
DISTRIBUTION Nationwide
WEEK ENDING APRIL 21
Jen-On Herbal Science International, Inc. Issues Recall of H S Joy of Love, a Product Marketed as a Dietary Supplement
Jen-On Herbal Science International, Inc. 205 Russell St., City of Industry, CA 91744, is conducting a recall of the company's supplement product sold under the name H S Joy of Love. H S Joy of Love contains Piperadino Vardenafil, an analog of Vardenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). Piperadino Vardenafil is close in structure to Vardenafil and is expected to possess a similar pharmacological and adverse event profile. This poses a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
H S Joy of Love is sold nationwide. The H S Joy of Love product is sold as a 12-capsule blister pack packaged in a retail box.
Consumers who have H S Joy of Love in their possession should stop using it immediately. In the event of any adverse side effects due to its consumption, consumers should contact a physician right away.
The company advises that any unused portion be returned to Jen-On Herbal Science International, Inc. for a full purchase price refund by calling (626) 333-9998 for instructions on the return and refund process.
PRODUCT Levoxyl,
Levothyroxine Sodium Tablets, USP, 125mcg, 100 count bottles, Rx only,
CODE
Lot Nos.: 37187, expiration 04/2008 and 37188,
expiration 04/2008
RECALLING FIRM/MANUFACTURER
Recalling
Firm: King Pharmaceuticals, Inc., Bristol, TN,
Manufacturer: King Pharmaceuticals, Inc, (St. Petersburg
Facility), St. Petersburg, FL.
REASON Adulterated presence of foreign tablet found in
bottle (Levoxyl 50mcg)
VOLUME OF PRODUCT IN COMMERCE 44,979
bottles
DISTRIBUTION Nationwide and PR
PRODUCT Senna Natural
Laxative Tablets (sennosides) 8.6 mg, 100 count bottles, Distributed by Eckerd
Drug Company, (SKU #: 516351 and 537765) and also Made for K-mart Corporation,
(SKU #: 384466-124 and 384466-116);
CODE Lot
numbers: (Eckerd) 6DB0241, 6DB0641, 6NB0082, 6MB0167 and (K-mart) 6CB0936,
6EB0509, 6MB0283, 6MB0282.
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Leiner Health Products LLC, Carson, CA,
Manufacturer: Time-Cap Labs, Farmingdale, NY.
REASON
Subpotent
VOLUME OF PRODUCT IN
COMMERCE 4082.4 tablets
DISTRIBUTION IL and RI
PRODUCT Fougera Amcinonide
Ointment USP, 0.1%, NET WT 30 grams, Rx only, NDC 0168-0279-30;
CODE
Lots S784 (exp. 6/07), T787 (exp. 11/07), U987
(exp. 4/08), U988 (exp. 4/08)
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Altana Inc., Melville NY,
Manufacturer: Altana Inc., Hicksville
NY
REASON Subpotent; (amcinonide
9-month)
VOLUME OF PRODUCT IN COMMERCE 18,482
units
DISTRIBUTION Nationwide and PR
WEEK ENDING APRIL 28
PRODUCT PAXIL CR Tablets, (Paroxetine
HCl), 12.5mg Controlled-Release Tablets, 30 tablet bottles, NDC
0029-3206-13,
CODE Lot # 9-6P06 Exp date
02-29-08, Lot # 14-6P06 Exp date 05-31-08, Lot # 15-6P06 Exp date 5-31-08 and
Lot # 16-6P06 Exp Date 05-31-08
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Smithkline Beecham
Pharmaceuticals Co., Cidra, PR,
Manufacturer: Sb Pharmco Puerto Rico, Inc.,
Cidra, PR.
REASON Incorrect Package Insert.
Medical Guidance leaflet may have an incorrect dosage strength
(25mg).
VOLUME OF PRODUCT IN COMMERCE 337,638
bottles
DISTRIBUTION Nationwide
PRODUCT 50% Urea Ointment In
a vehicle containing Vitamin E, Lactic Acid and Zinc, Rx Only, Net Wt. 1.5 oz
(45 g), NDC 68032-130-45,
CODE Lot numbers:
5553, 5554 and 5555
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Rivers Edge Pharmaceuticals, Suwanee, GA.,
Manufacturer: Sonar Products, Inc., Carlstadt, NJ.
REASON
Crystallization; Urea crystals
are forming in the ointment base.
VOLUME OF PRODUCT IN
COMMERCE 1,524 units
DISTRIBUTION Nationwide
PRODUCT Sleepinal Softgels, (Diphenhydramine Hydrochloride), 50mg, 16 count
blisterpacks, Maximum Strength,
night-time sleep-aid, UPC 3-50486-621-16-0,
CODE Lots 10574002A, 10574003, 10574004. Expiration
Date: Nov-06
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Blairex Laboratories, Inc., Columbus, IN.,
Manufacturer: Strides, Inc., Somerset, NJ.
REASON
Failed USP Dissolution Requirement; 21 month
test station
VOLUME OF PRODUCT IN COMMERCE 57,378
capsules
DISTRIBUTION Nationwide