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SafetyAlerts
May 31, 2000

Roberts Pharmaceuticals Brand 'Entuss-D liquid Antitussive' Recalled for Subpotency

Seymour, IN (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Schwarz Pharma Manufacturing, Inc., of Seymour, Indiana is conducting a recall of Roberts Pharmaceuticals brand Entuss-D liquid Antitussive, nasal decongestant, expectorant. 16 fl. Oz., (Rx Control Schedule III. Contains hydrocodone bitartrate 5 mg., pseudoephedrine hydrochloride 30 mg., potassium guaiacolsulfonate 300 mg per 5 ml.) because of subpotency (24 month stability).

The product is coded with M78280 EXP 12/00.

FDA stated in its report that 3,344 bottles were distributed to California and New Jersey.  FDA indicated in its report that the company had completed all requirements for the recall.

This ongoing Class III recall was initiated by the company, by letter dated January 10, 2000.  This is the first public notice issued by the FDA.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #d-387-0
NDC 54092-438-16

Notice of this product warning was sent via email to SafeMail subscribers May 31, 2000.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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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.