Reported Feb 27, 2019 · Terminated
Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles,…
Lupin Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lupin Pharmaceuticals Inc. · 111 S Calvert St Fl 21ST · Baltimore, MD · 21202-6174
Is this the product you have?
- 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 forLupin Pharmaceuticals, Inc., Baltimore, Maryland 21202
- Manufactured byLupin Limited, Goa 403 722 INDIA
- Lot codes and dates
Lot #: a) G702755Exp March 2020b) G702756Exp March 2020
- Amount recalled
- 44,640 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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