Drug 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
D-0352-2019
Product summary
- Event
- Event 81896
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,060 units
- Official record key
drug-enforcement:D-0352-2019
Official wording
Reason: Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
Code information: Lot #: VCIA082, Exp. MAY 2020; VCIA083, VCIA084, Exp. JUNE 2020
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility