Memantine Hydrochloride Extended-Release Capsules Recalled for Dissolution Failures
The Harvard Drug Group is recalling 678 cartons of Memantine Hydrochloride Extended-Release Capsules due to low stage 3 dissolution results found during routine stability testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The issue is a failure in dissolution specifications, which is a quality control defect rather than a direct safety hazard like contamination or mislabeling.
Plain-English summary
The Harvard Drug Group is recalling 678 cartons of Memantine Hydrochloride Extended-Release Capsules, 28 mg. The product is distributed in unit dose cartons containing 100 capsules each. The specific lots affected are M02199D and M02246D, with an expiration date of 5/2020.
The recall was initiated because low stage 3 results were obtained for dissolution during routine stability testing. This indicates that the capsules may not release the medication as intended. The product is manufactured by Lupin Limited in India and distributed by Major Pharmaceuticals in Livonia, Michigan.
The affected product was distributed to Alabama, Florida, Iowa, New York, Ohio, and Texas. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or refund.
The recalled product
- Product
- MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE)
- Brand
- MEMANTINE HYDROCHLORIDE
- Manufacturer
- The Harvard Drug Group
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 678
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: M02199D
- M02246D
- Exp 5/2020
Distribution
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