Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawadi, Pune, India, Mfg for: Heritage Pharmaceuticals Inc. UPC 323155216388, NDC 23155-216-31
Reported: October 31, 2018 Initiated: October 15, 2018 #D-0094-2019
Product Description
Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawadi, Pune, India, Mfg for: Heritage Pharmaceuticals Inc. UPC 323155216388, NDC 23155-216-31
Reason for Recall
Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
Details
- Recalling Firm
- Heritage Pharmaceuticals, Inc.
- Units Affected
- 2,789 Units
- Distribution
- Nationwide within the United States
- Location
- East Brunswick, NJ
Frequently Asked Questions
What product was recalled? ▼
Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawadi, Pune, India, Mfg for: Heritage Pharmaceuticals Inc. UPC 323155216388, NDC 23155-216-31. Recalled by Heritage Pharmaceuticals, Inc.. Units affected: 2,789 Units.
Why was this product recalled? ▼
Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 31, 2018. Severity: Moderate. Recall number: D-0094-2019.
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