# FDA recall D-1397-2019

> **Heritage Pharmaceuticals, Inc.** · Class I · drug recall initiated 2019-05-21.

## Product

PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India. Mfg for: Heritage Pharmaceuticals Inc. NDC 23155-294-31

## Reason for recall

Non-Sterility:Microbial growth detected in  sub lot of  Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1397-2019
- **Recalling firm:** Heritage Pharmaceuticals, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-05-21
- **Report date:** 2019-06-19
- **Termination date:** 2022-01-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Brunswick, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1397-2019

## Citation

> AI Analytics. FDA recall D-1397-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1397-2019. Source: US FDA. Licensed CC0.

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