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, 473 mL (1 pint) syrup, Rx only. Recall # D-270-3.

CODE
Lot 20920.

RECALLING FIRM/MANUFACTURER
Schwarz Pharma Manufacturing, Seymour, IN, by telephone on April 7, 2003, and by letters on May 14, 2003. 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.