D-0012-2016 Class III Terminated
FDA drug recall D-0012-2016 was initiated by Boehringer Ingelheim Roxane Inc on September 25, 2015 and is designated Class III. 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. The recall status is terminated (terminated February 19, 2016). Affected quantity: 5,160 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 21, 2015
- Initiation Date
- September 25, 2015
- Termination Date
- February 19, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,160 bottles
Product Description
FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4299-31, UPC 3 0054-4299-31 2.
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 Pattern
Nationwide and Puerto Rico
Code Information
Lot #: 559310P, Exp 02/17; 559664B, Exp 04/17