Reported Dec 25, 2019 · Terminated
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b)…
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. · Harborplace Tower · Baltimore, MD · 21202-6174
Is this the product you have?
- Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68180-249-02); Rx only
- Manufactured forLupin Pharmaceuticals, Inc., Baltimore, Maryland 21202
- Manufactured byLupin Limited, Pithampur (M.P.)-454 775, INDIA
- Lot codes and dates
Lot #: H901787H901788Exp March 2021
- Amount recalled
- 3,726 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: High out of specification result observed at stability studies.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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