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SafetyAlerts
November 26,  2003

Bristol-Myers Squibb Has Recalled Comtrex SOFTGELS

(SafetyAlerts) - The FDA has released the following information.

PRODUCT
Comtrex SOFTGELS, Multi-Symptom, Deep Chest Cold, Pain Reliever/Fever Reducer, Expectorant, Cough Suppressant, Nasal Decongestant, 20 and 30 softgel capsule cartons. Active ingredients: Acetaminophen 250 mg., DexProduct Description (Label/Packaging) tromethorphan HBr 10 mg., Guaifenesin 100 mg., Pseudoephedrine HCl 30 mg. Recall # D-059-4.

CODE
20 Count Package, Lot Number/Expiration Date; 205564 Feb 04, 205601 Feb 04, 205602 Feb 04, 207549 Feb 04, 207550 May 04, 207551 June 04, 207598 June 04, 208557 June 04, 208558 June 04, 208559 June 04, 210503 June 04, 210504 June 04, 210505 June 04, 210506 July 05, 210507 July 05, 210508 July 05, 210509 July 05, 210510 July 05, 210532 July 05, 210533 Aug 04, 210593 July 04, 210594 Aug 04, 210595 Aug 04, 210622 July 04, 301507 May 04, 301508 Nov 04, 301556 Nov 04, 301557 Nov 04, 301558 Nov 04, 302578 Dec 04, 302579 Dec 04, 302580 Dec 04, 302592 Dec 04, 303567 Dec 04, 308511 May 05. 30 Count Package, Lot Number/Expiration Date; 306588 May 05, 308510 May 05, 308535 May 05, 309538 July 05, 309544 July 05. Display Number 1018: A3H1A May 05, A3H1C, May 05 Display Number 1081: A3H1A May 05.

RECALLING FIRM/MANUFACTURER
Bristol-Myers Squibb Co., Hillside, NJ, by letter on October 1, 2003. Firm initiated recall is ongoing.

REASON
Mis-Labeling: The dosing instructions incorrectly declare a maximum dose of 12 caps per 24 hour period (the maximum recommended dose should read 8 caps per 24 hour period).

VOLUME OF PRODUCT IN COMMERCE
67,706 packages.

DISTRIBUTION
Nationwide and Trinidad.

 
Selected Recent Recalls


Health Professional:

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During 2000 there were over
1050 products recalled in the United
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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.