# FDA recall D-0844-2020

> **The Harvard Drug Group** · Class III · drug recall initiated 2019-12-13.

## Product

Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured for:  Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Distributed by:  Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6735-61

## Reason for recall

Failed Dissolution Specifications: High out of specification result observed at stability studies.

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-0844-2020
- **Recalling firm:** The Harvard Drug Group
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-12-13
- **Report date:** 2020-02-26
- **Termination date:** 2020-11-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Livonia, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0844-2020

## Citation

> AI Analytics. FDA recall D-0844-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0844-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*