# FDA recall D-0014-2016

> **Actavis Laboratories, FL, Inc.** · Class II · drug recall initiated 2015-09-25.

## Product

Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL  33314 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ  07054 USA; NDC 0591-2720-60; UPC 3 05912 72060 3.

## Reason for recall

Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0014-2016
- **Recalling firm:** Actavis Laboratories, FL, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-09-25
- **Report date:** 2015-10-21
- **Termination date:** 2017-04-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Davie, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0014-2016

## Citation

> AI Analytics. FDA recall D-0014-2016. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0014-2016. Source: US FDA. Licensed CC0.

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