Drug recall D-0094-2019

Class II Terminated reported Oct 31, 2018

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

Reason for recall

Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle

Lots and codes

Lot #: VCIA083, Exp. JUN2020

Recall details

Recalling firm
Heritage Pharmaceuticals, Inc., East Brunswick, NJ
Quantity
2,789 Units
Distribution
Nationwide within the United States
Type
Voluntary: Firm initiated
Recall initiated
October 15, 2018
Terminated
March 29, 2023

Related products