FDA-Drug2019-02-27Class III
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.
Lupin Pharmaceuticals Inc.
Hazard
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Sold states
Nationwide in the USA and Puerto Rico.
Affected count
44,640 bottles
Manufactured in
111 S Calvert St Fl 21ST, Baltimore, MD, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0513-2019Don't want to check this manually?
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