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SafetyAlerts
July 9, 2003

Schwarz Pharma Has Recalled Levsin Elixir

(SafetyAlerts) - 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
.

 
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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.