Recalls / Class II
Class IID-0352-2019
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
- Affected lot / code info
- Lot #: VCIA082, Exp. MAY 2020; VCIA083, VCIA084, Exp. JUNE 2020
Why it was recalled
Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
Recalling firm
- Firm
- Heritage Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Tower Center Blvd Ste 1700, East Brunswick, New Jersey 08816-1145
Distribution
- Quantity
- 5,060 units
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2019-01-02
- FDA classified
- 2019-01-08
- Posted by FDA
- 2019-01-16
- Terminated
- 2021-02-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0352-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.