May 31, 2000Roberts Pharmaceuticals Brand
'Entuss-D liquid Antitussive' Recalled for Subpotency
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
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
Notice of this product warning was
sent via email to SafeMail
subscribers May 31, 2000.
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