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SafetyAlerts
April 11, 2002

Pharmaceutical Associates Has Recalled Chloral Hydrate Syrup and Phenobarbital Elixir

Greenville, SC  (SafetyAlerts) - The Food and Drug Administration (FDA) said that Pharmaceutical Associates, Inc has recalled Chloral Hydrate Syrup and Phenobarbital Elixir.

PRODUCT
a) Chloral Hydrate Syrup USP, 500 mg/5mL, 5 mL unit dose cups, 10 cups per tray, 10 trays per case. Recall # D-225-2.
b) Phenobarbital Elixir, 20 mg/5 mL, 5 mL unit dose cups, 10 cups per tray, 10 trays per case. Recall # D-226-2.

CODE
a) Lots 1E46, 1H52, 1K17
NDC-0121-0532-05
b) Lot 1K49
NDC-0121-0531-05.

RECALLING FIRM/MANUFACTURER
Pharmaceutical Associates, Inc., Greenville, SC, by letter on March 4, 2002. Firm initiated recall is ongoing.

REASON
Overfill of drug cups which could lead to twice the labeled amount of active ingredient being dispensed.

VOLUME OF PRODUCT IN COMMERCE
a) 284,860/5 mL cups;
b) 4,207/5 mL cups.

DISTRIBUTION
Nationwide
.

 
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.