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SafetyAlerts
July 23, 2003

 

Schwarz Pharma Has Recalled Levsin Elixir

The Food and Drug Administration (FDA) released the following information.

PRODUCT
Levsin Elixir (hyoscyamine sulfate elixir USP), 0.125 mg/mL 473mL (l pint) syrup, Rx only. Recall # D-270-3.

CODE
Lot 20920.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Schwarz Pharma Manufacturing, Seymour, IN, by telephone on April 7, 2003 and by letters on May 14, 2003.
Manufacturer: Elge Inc., Rosenberg, TX. Firm initiated recall is ongoing.

REASON
Mislabeled front label incorrectly states the product strength as 0.125 mg/mL rather than correctly as 0.125 mg/5 mL.

VOLUME OF PRODUCT IN COMMERCE
393 bottles.

DISTRIBUTION
Nationwide.
 

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