Reported Feb 26, 2020 · Terminated
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only,…
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, 28mg, packaged in 100-count Unit Dose Cartons , Rx only
- Manufactured forLupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States
- Distributed by
Major Pharmaceuticals17177 N Laurel Park DrSuite 233LivoniaMI 48152 USANDC 0904-6735-61
- Lot codes and dates
- Lot# M02465D
- Amount recalled
- 246 Cartons
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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