Drug recall D-0011-2016
Product
FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4297-31, UPC 3 0054-4297-31 8.
Reason for recall
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Lots and codes
Lot #: 559660P, 559661P, Exp 03/17
Recall details
- Recalling firm
- Boehringer Ingelheim Roxane Inc, Columbus, OH
- Quantity
- 11,110 bottles
- Distribution
- Nationwide and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 25, 2015
- Terminated
- February 19, 2016
Related products
- Furosemide – drug information
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