Lovastatin Tablets USP recalled over manufacturing violations
- Recall date
- February 19, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- American Health Packaging recalls Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-…
- Recall number
- D-1584-2019
- FDA classification
- Class III
- Brand / firm
- American Health Packaging
- Sold / distributed
- Nationwide within 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) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, Manufactured by: Lupin Limited, Goa 403 722 INDIA For BluePoint Laboratories.
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