Lovastatin Tablets USP recalled over manufacturing violations
- Recall date
- February 13, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Lupin Pharmaceuticals Inc. recalls Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, R…
- Recall number
- D-0513-2019
- FDA classification
- Class III
- Brand / firm
- Lupin Pharmaceuticals Inc.
- Sold / distributed
- Nationwide in the USA and Puerto Rico.
Why it was recalled
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Class III means the product violates regulations but is not likely to cause harm.
What 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.
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