Class III
Terminated
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.
- Company
- Boehringer Ingelheim Roxane Inc
- Recall Initiated
- September 25, 2015
- Posted
- October 21, 2015
- Recall Number
- D-0011-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 11,110 bottles
- Firm Location
- Columbus, OH, United States
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.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #: 559660P, 559661P, Exp 03/17
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