Recalls / Class II
Class IID-0378-2021
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
- Affected lot / code info
- Lot # 31325394C, exp. date 09/2021 Lot # 31327161B, exp. date 04/2022
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 7020 vials
- Distribution pattern
- Product was distributed nationwide.
Timeline
- Recall initiated
- 2021-04-26
- FDA classified
- 2021-05-14
- Posted by FDA
- 2021-05-26
- Terminated
- 2024-06-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0378-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.