# FDA recall D-0352-2019

> **Heritage Pharmaceuticals, Inc.** · Class II · drug recall initiated 2019-01-02.

## Product

Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India  Mfg. for : Heritage Pharmaceuticals Inc. NDC 23155-0216-31

## Reason for recall

Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0352-2019
- **Recalling firm:** Heritage Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-01-02
- **Report date:** 2019-01-16
- **Termination date:** 2021-02-19

- **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-0352-2019

## Citation

> AI Analytics. FDA recall D-0352-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0352-2019. Source: US FDA. Licensed CC0.

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