Why it was recalled
Subpotent Drug
Product description
Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56
Lot numbers, UPCs & expiration codes
Lot #: FE22001A, Exp. Date 01/2024
Where it was sold
Nationwide within the USA
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-1349-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 27, 2022
- FDA report date
- Aug 24, 2022
- Quantity
- 4,160 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amerisource Health Services LLC
Original FDA data
Every field from FDA enforcement report D-1349-2022, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 90677
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot #: FE22001A, Exp. Date 01/2024
- Postal code
- 43217-1188
- Report date
- Aug 24, 2022
- Product type
- Drugs
- Recall number
- D-1349-2022
- Classification
- Class III
- Recalling firm
- Amerisource Health Services LLC
- Product quantity
- 4,160 vials
- Termination date
- Sep 28, 2023
- Reason for recall
- Subpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56
- Distribution pattern
- Nationwide within the USA
- Recall initiation date
- Jul 27, 2022
- Initial firm notification
- Letter
- Center classification date
- Aug 17, 2022