# FDA recall D-1677-2012

> **Sandoz Incorporated** · Class III · drug recall initiated 2012-09-12.

## Product

Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781-  5249-92,

## Reason for recall

Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1677-2012
- **Recalling firm:** Sandoz Incorporated
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-09-12
- **Report date:** 2012-09-26
- **Termination date:** 2013-04-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Broomfield, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1677-2012

## Citation

> AI Analytics. FDA recall D-1677-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1677-2012. Source: US FDA. Licensed CC0.

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