D-0094-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 31, 2018
- Initiation Date
- October 15, 2018
- Termination Date
- March 29, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,789 Units
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
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: VCIA083, Exp. JUN2020