Drug product
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
D-0094-2019
Product summary
- Event
- Event 81276
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,789 Units
- Official record key
drug-enforcement:D-0094-2019
Official wording
Reason: Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
Code information: Lot #: VCIA083, Exp. JUN2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility