# FDA recall D-0839-2018

> **Apotex Inc.** · Class I · drug recall initiated 2018-05-08.

## Product

Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India  Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0687-4

## Reason for recall

Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0839-2018
- **Recalling firm:** Apotex Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-05-08
- **Report date:** 2018-05-23
- **Termination date:** 2023-10-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North York, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0839-2018

## Citation

> AI Analytics. FDA recall D-0839-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0839-2018. Source: US FDA. Licensed CC0.

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