# FDA recall D-1288-2020

> **The Harvard Drug Group** · Class II · drug recall initiated 2020-05-22.

## Product

Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit dose carton (NDC 0904-0430-06), Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; Distributed by:  Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152.

## Reason for recall

Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-1288-2020
- **Recalling firm:** The Harvard Drug Group
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-05-22
- **Report date:** 2020-06-10
- **Termination date:** 2022-10-02

- **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-1288-2020

## Citation

> AI Analytics. FDA recall D-1288-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1288-2020. Source: US FDA. Licensed CC0.

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