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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
April 28, 1999

Horizon Pharmaceutical Brand Protuss-DM Tablets Recalled

PRODUCT
Horizon Pharmaceutical brand Protuss-DM Tablets (Dextromethorphan Hbr 30 mg, Pseudoephedrine HCl 60mg, Guaifenesin 600 mg), Sustained-Release, in 100 tablet bottles, Rx antitussive/decongestant/ expectorant. NDC #59630-160-10.
Recall #D-192-9.

CODE
Lot #T6370J05 EXP 11/00.

MANUFACTURER
Anabolic Laboratories, Inc., Irvine, California.

RECALLED BY
Manufacturer, by letter on January 18, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Undetermined.

QUANTITY
Approximately 2,739 bottles were distributed; firm estimates none remains on the market.

REASON
Mislabeling - Immediate bottle label incorrectly declares Pseudoephedrine HCl at 120mg per tablet (correctly labeled insert shows 60 mg per tablet).

 

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.