Class II
Terminated
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.
This recall has been terminated (originally issued August 25, 2021).
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- July 29, 2021
- Posted
- August 25, 2021
- Recall Number
- D-0732-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 16,226 vials
- Firm Location
- Parsippany, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility
Distribution
Product was distributed Nationwide, including Puerto Rico.
Lot / Code Info
Lot #: a) 31327056B, exp. date 03/2022; 31328547B, exp. date 01/2023; b) 31327066B, exp. date 03/2022
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