Class II · Moderate risk
Memantine Hydrochloride Extended-Release
Failed Dissolution Specifications
Namzaric (memantine HCl extended release and donepezil HCl)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
Namzaric (memantine HCl extended release and donepezil HCl) capsules 14 mg/10 mg per capsule 30 capsules Rx Only NDC 0456-1214-30 Distributed by Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, LLC.
Affected NDC
0456-1214-30
Compare with the code on your package — it is the most precise check available.
Drug: Memantine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Namzaric memantine hydrochloride and donepezil hydrochloride NDC 00456-1214 |
MEMANTINE HYDROCHLORIDE 14 mg/1; DONEPEZIL HYDROCHLORIDE 10 mg/1 | Capsule Oral |
Allergan, Inc. | Rx |
- Recalling firm
- Cardinal Health Inc.
- NDC code
- 0456-1214-30
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0418-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Memantine recalls
See all
Class III · Low risk
Memantine Hydrochloride Extended-Release Capsules
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Class II · Moderate risk
Memantine Hydrochloride Extended Release Capsules
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Class III · Low risk
Memantine Hydrochloride Extended-release Capsules
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Class III · Low risk
Memantine Hydrochloride Extended-release Capsules
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Other recalls by Cardinal Health Inc.
All 2021 recalls
Class II · Moderate risk
Enoxaparin Sodium Injection
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Class II · Moderate risk
Recombinate
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
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