# FDA recall D-835-2013

> **Apotex Corp.** · Class I · drug recall initiated 2013-05-10.

## Product

Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0

## Reason for recall

Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-835-2013
- **Recalling firm:** Apotex Corp.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-05-10
- **Report date:** 2013-08-14
- **Termination date:** 2018-01-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Weston, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-835-2013

## Citation

> AI Analytics. FDA recall D-835-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-835-2013. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
