Recalls / Class II
Class IID-0094-2019
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
- Brand name
- Cidofovir Dihydrate
- Generic name
- Cidofovir Dihydrate
- Active ingredient
- Cidofovir
- Route
- Intravenous
- NDC
- 23155-216
- FDA application
- ANDA202501
- Affected lot / code info
- Lot #: VCIA083, Exp. JUN2020
Why it was recalled
Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
Recalling firm
- Firm
- Heritage Pharmaceuticals, Inc.
- Manufacturer
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Tower Center Blvd Ste 1700, N/A, East Brunswick, New Jersey 08816-1145
Distribution
- Quantity
- 2,789 Units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2018-10-15
- FDA classified
- 2018-10-24
- Posted by FDA
- 2018-10-31
- Terminated
- 2023-03-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0094-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.