# FDA recall D-0838-2020

> **Macleods Pharma Usa Inc** · Class III · drug recall initiated 2020-01-24.

## Product

Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India, NDA 33342-176-09

## Reason for recall

Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0838-2020
- **Recalling firm:** Macleods Pharma Usa Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-01-24
- **Report date:** 2020-02-12
- **Termination date:** 2022-12-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plainsboro, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0838-2020

## Citation

> AI Analytics. FDA recall D-0838-2020. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0838-2020. Source: US FDA. Licensed CC0.

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