D-0352-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 16, 2019
- Initiation Date
- January 2, 2019
- Termination Date
- February 19, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,060 units
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
Distribution Pattern
Nationwide
Code Information
Lot #: VCIA082, Exp. MAY 2020; VCIA083, VCIA084, Exp. JUNE 2020