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
Reported: January 16, 2019 Initiated: January 2, 2019 #D-0352-2019
Product Description
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
Details
- Recalling Firm
- Heritage Pharmaceuticals, Inc.
- Units Affected
- 5,060 units
- Distribution
- Nationwide
- Location
- East Brunswick, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Heritage Pharmaceuticals, Inc.. Units affected: 5,060 units.
Why was this product recalled? ▼
Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 16, 2019. Severity: Moderate. Recall number: D-0352-2019.
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