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.
Reported: February 27, 2019 Initiated: February 13, 2019 #D-0513-2019
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.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 44,640 bottles
- Distribution
- Nationwide in the USA and Puerto Rico.
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 44,640 bottles.
Why was this product recalled? ▼
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 27, 2019. Severity: Low. Recall number: D-0513-2019.
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