Reported May 20, 2020 · Terminated
Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by:…
The Harvard Drug Group
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: The Harvard Drug Group · 17177 N Laurel Park Dr Ste 233 · Livonia, MI · 48152-3951
Is this the product you have?
- Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only
- Manufactured byLupin Limited, Pithampur (M.P.)-454 775, India
- Distributed by
Major Pharmaceuticals17177 N Laurel Park DrSuite 233LivoniaMI 47152 USA
- NDC0904-6735-61
- Lot codes and dates
Lot #: M02199DM02246DExp 5/2020
- Amount recalled
- 678 cartons
Where it was sold
Why it was recalled
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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