# FDA recall D-0013-2018

> **The Harvard Drug Group** · Class II · drug recall initiated 2017-09-26.

## Product

Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ  07054; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-5858-61.

## Reason for recall

Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0013-2018
- **Recalling firm:** The Harvard Drug Group
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-09-26
- **Report date:** 2017-10-25
- **Termination date:** 2020-04-29

- **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-0013-2018

## Citation

> AI Analytics. FDA recall D-0013-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0013-2018. Source: US FDA. Licensed CC0.

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