# FDA recall D-0653-2016

> **Macleods Pharma Usa Inc** · Class II · drug recall initiated 2015-12-24.

## Product

Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA. NDC: 33342-031-10.

## Reason for recall

Presence of Foreign Tablets/Capsules:  Presence of a comingled Carbimazole 5 mg tablet.

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-0653-2016
- **Recalling firm:** Macleods Pharma Usa Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-12-24
- **Report date:** 2016-02-17
- **Termination date:** 2020-08-31

- **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-0653-2016

## Citation

> AI Analytics. FDA recall D-0653-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0653-2016. Source: US FDA. Licensed CC0.

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