FEBRUARY 2003

 

WEEK ENDING FEBRUARY 15

 

PRODUCT
 a) Methylprednisolone Acetate Injection, Suspension, 40mg/ml, Single dose, Preservative Free, 20 mL vial.
 b) Methylprednisolone Acetate Injection, Suspension, 80mg/ml, Single dose, Preservative Free, 20 mL vial.
 CODE  All lot codes.
RECALLING FIRM/MANUFACTURER Urgent Care Pharmacy, Spartanburg, SC

REASON Microbial contamination.
VOLUME OF PRODUCT IN COMMERCE
a) 145 units;
b) 1283 units.
DISTRIBUTION CN, MA, NC, SC, VA.


PRODUCT
a) Caverject (alprostadil for injection), 5 mcg, single  dose vials, Rx only, For intracavernosal use only. NDC 0009-7212-03.
b) Caverject (alprostadil for injection), 10 mcg, single dose vials, Rx only, For intracavernosal use only. NDC-0009-3778-08.
c) Caverject (alprostadil for injection), 20 mcg, single dose vials, Rx only, For intracavernosal use only. NDC 0009-3701-01 and NDC 0009-3701-96 (Physician samples

CODE
a) Lot Expiration date 31HPU 02/2004.
b) Lot Exp. Date 08HRJ 03/2004;20HYA 05/2004; 26HPJ 01/2004; 66HCK 08/2003;  80FPM 01/2003.Foreign Distribution (New Zealand, Hong Kong, Singapore) HI1577 11/2002; IC1411 01/2003; IF1015 04/2003.
c) 04HHP 02/2003; 06HKP 03/2003; 22HHF 01/2003; 33HPU 05/2003; 40HSU 07/2003; 54HDC 11/2002; 58HRY 06/2003;
64HCK 11/2002, 66HWS 07/2003; 73JBT 10/2003; 75HDJ 11/2002; 78HFF 12/2002; 84HJT 02/2003; 86HFS 12/2002;
87HFS 12/2002; Physician Samples: 08HMC 03/2003; 21HHF 12/2002; 57HRY 06/2003; 80HDU 11/2002.Foreign Distribution (New Zealand, Hong Kong, and Singapore): IA1289 12/2002; IB0591 12/2002; IB1100 12/2002; IC1410 01/2003; ID0900 03/2003; IF0207 03/2003; II1204 06/2003; JC1316 01/2004; JE0747 03/2004.

RECALLING FIRM/MANUFACTURER Pharmacia Corporation, Kalamazoo, MI

REASON Lack of assurance of sterility for the prefilled diluent syringes packaged for use with the product.
VOLUME OF PRODUCT IN COMMERCE
a) 1,623 units;
b) 35,450 units;
c) 139,081 units.
DISTRIBUTION Nationwide and Internationally.


PRODUCT AVC Suppositories (sulfanilamide) 1.05 grams, 16 vaginal suppositories per box with an inserter, Rx only.
 CODE 2C01AS, Exp. 04/2003.
RECALLING FIRM/MANUFACTURER Recalling Firm: Fielding Pharmaceutical Co., Maryland Heights, MO

Manufacturer: R.P. Scherer, St. Petersburg, FL. Firm initiated recall is complete.
REASON Stability; product was distributed in a new container closure system without stability data to support expiration dating.
VOLUME OF PRODUCT IN COMMERCE 6,120 boxes.
DISTRIBUTION Nationwide.

 

WEEK ENDING FEBRUARY 22

 

Best Life International, Inc. is recalling all 100 tablet bottles of Ancom Anti-Hypertensive Compound Tablets, an unapproved new drug labeled to contain several prescription drug ingredients, including reserpine, diazepam, promethiazine, and hydrochlorothiazide. The sale of a product with this combination of ingredients poses possible serious health risks including sedation, depression, and potentially life-threatening abnormalities of the blood. This recall includes all lot codes of the product remaining on the market.

 

Ancom Tablets were sold without prescriptions to consumers through distributors and retail stores of natural products throughout the Island of Puerto Rico. The product is labeled for anti-hypertensive use and is packaged in white plastic bottles of 100 tablets bearing blue and white lettered labeling. Each bottle is sold in an outer cardboard holding carton. Both the carton and immediate container label bear the product name as Ancom tablets, Anti-hypertensive Compound, and display the manufacture’s name as Shanghai Pharmaceutical Industry Corp., Shanghai, China. The labeling also bears Chinese markings, which appear to be dual declarations. The holding carton is white with a pink and blue vertical stripe bearing blue and white lettering. The product carton also includes a pre-printed insert labeled with an ingredient statement and directions for use.

 

Consumers who have used this product and are experiencing any adverse reactions should seek advice from their physician for appropriate evaluation and treatment of their hypertension.

 

Consumers who purchased Ancom Anti-Hypertensive Compound Tablets are urged to immediately discontinue use of the product and return it to the place of purchase for a full refund. Consumers with questions may contact the company at 787-832-3287.

 

PRODUCT Nature-Throid NT-2, (Thyroid, U.S.P), 129.6 mg, 100 tablet bottles, Rx only

CODE  Lot B036N Expiration date 03/05.

RECALLING FIRM/MANUFACTURER RSJ, Inc., Phoenix, AZ.,

REASON Mislabeled bottles labeled to contain Nature-Throid NT-2 (129.6mg) actually contains Nature-Throid NT-1 (65mg).

VOLUME OF PRODUCT IN COMMERCE 360 bottles.

DISTRIBUTION Nationwide.