D-0513-2019 Class III Terminated
FDA drug recall D-0513-2019 was initiated by Lupin Pharmaceuticals Inc. on February 13, 2019 and is designated Class III. Reason for recall: CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results. The recall status is terminated (terminated October 6, 2020). Affected quantity: 44,640 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 27, 2019
- Initiation Date
- February 13, 2019
- Termination Date
- October 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44,640 bottles
Product Description
Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA.
Reason for Recall
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Code Information
Lot #: a) G702755, Exp March 2020; b) G702756, Exp March 2020