D-0732-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 25, 2021
- Initiation Date
- July 29, 2021
- Termination Date
- June 4, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16,226 vials
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Product was distributed Nationwide, including Puerto Rico.
Code Information
Lot #: a) 31327056B, exp. date 03/2022; 31328547B, exp. date 01/2023; b) 31327066B, exp. date 03/2022