April 11, 2002Pharmaceutical 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.
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.
a) Lots 1E46, 1H52, 1K17
b) Lot 1K49
Pharmaceutical Associates, Inc., Greenville, SC, by letter on March 4, 2002.
Firm initiated recall is ongoing.
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.