Why it was recalled
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Product description
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
Lot numbers, UPCs & expiration codes
Lot: FE22001A, Exp 01/2024
Where it was sold
Distributed in Ohio
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-1334-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 22, 2022
- FDA report date
- Aug 17, 2022
- Quantity
- 4162 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-1334-2022, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90594
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot: FE22001A, Exp 01/2024
- Postal code
- 07054-1120
- Report date
- Aug 17, 2022
- Product type
- Drugs
- Recall number
- D-1334-2022
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA Inc
- Product quantity
- 4162 cartons
- Termination date
- Apr 12, 2023
- Reason for recall
- Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
- Distribution pattern
- Distributed in Ohio
- Recall initiation date
- Jul 22, 2022
- Initial firm notification
- Letter
- Center classification date
- Aug 11, 2022