Drug product
Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7133-01), Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454.
D-0732-2021
Product summary
- Event
- Event 88442
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16,226 vials
- Official record key
drug-enforcement:D-0732-2021
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: a) 31327056B, exp. date 03/2022; 31328547B, exp. date 01/2023; b) 31327066B, exp. date 03/2022
Distribution pattern: Product was distributed Nationwide, including Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility