D-0378-2021 Class II Terminated
FDA drug recall D-0378-2021 was initiated by Teva Pharmaceuticals USA on April 26, 2021 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated June 4, 2024). Affected quantity: 7020 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- May 26, 2021
- Initiation Date
- April 26, 2021
- Termination Date
- June 4, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7020 vials
Product Description
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
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Product was distributed nationwide.
Code Information
Lot # 31325394C, exp. date 09/2021 Lot # 31327161B, exp. date 04/2022