# FDA recall D-1851-2019

> **Macleods Pharma Usa Inc** · Class III · drug recall initiated 2019-08-21.

## Product

Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536,  Manufactured by: Macleods Phamaceuticals Ltd. Baddi Himachal Pradesh, India. NDC 33342-031-10

## Reason for recall

Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-1851-2019
- **Recalling firm:** Macleods Pharma Usa Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-08-21
- **Report date:** 2019-09-18
- **Termination date:** 2021-01-28

- **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-1851-2019

## Citation

> AI Analytics. FDA recall D-1851-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1851-2019. Source: US FDA. Licensed CC0.

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