FDA-Drug2019-08-14Class III
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.
American Health Packaging
Hazard
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Sold states
Nationwide within the USA and Puerto Rico
Affected count
14,360 bottles
Manufactured in
2550 John Glenn Ave Ste A, N/A, Columbus, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1584-2019Don't want to check this manually?
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