# FDA recall D-0010-2018

> **Unichem Pharmaceuticals Usa Inc** · Class II · drug recall initiated 2017-10-02.

## Product

Bisoprolol Fumarate tablets,  5 mg,  30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa, 403 511, India, Marketed by: UNICHEM PHARMACEUTICALS, (USA), INC. Hasbrouck Heights, NJ 07604, NDC 29300-126-13.

## Reason for recall

Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity  was observed during the 18 month stability testing.

## Distribution

Product was distributed nationwide

## Key facts

- **Recall number:** D-0010-2018
- **Recalling firm:** Unichem Pharmaceuticals Usa Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-10-02
- **Report date:** 2017-10-25
- **Termination date:** 2018-09-13

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0010-2018

## Citation

> AI Analytics. FDA recall D-0010-2018. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0010-2018. Source: US FDA. Licensed CC0.

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