FDA-Drug2019-01-16Class II

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

Heritage Pharmaceuticals, Inc.
Hazard

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

Sold states
Nationwide
Affected count
5,060 units
Manufactured in
1 Tower Center Blvd Ste 1700, East Brunswick, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0352-2019

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief