Why it was recalled
Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: VCIA082, Exp. MAY 2020; VCIA083, VCIA084, Exp. JUNE 2020
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0352-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 2, 2019
- FDA report date
- Jan 16, 2019
- Quantity
- 5,060 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Heritage Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0352-2019, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 81896
- Address
- 1 Tower Center Blvd Ste 1700
- Code information
- Lot #: VCIA082, Exp. MAY 2020; VCIA083, VCIA084, Exp. JUNE 2020
- Postal code
- 08816-1145
- Report date
- Jan 16, 2019
- Product type
- Drugs
- Recall number
- D-0352-2019
- Classification
- Class II
- Recalling firm
- Heritage Pharmaceuticals, Inc.
- Product quantity
- 5,060 units
- Termination date
- Feb 19, 2021
- Reason for recall
- Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 2, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 8, 2019