Drug product
Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 0703-7131-03
D-0378-2021
Product summary
- Event
- Event 87875
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7020 vials
- Official record key
drug-enforcement:D-0378-2021
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot # 31325394C, exp. date 09/2021 Lot # 31327161B, exp. date 04/2022
Distribution pattern: Product was distributed nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility