Recalls / Class II
Class IID-0294-2022
Product
Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (NDC 00093-4125-74) (when mixed) bottles, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454
- Affected lot / code info
- a) Lots, 35446365A, Exp 03/2022; 35447040A, Exp 08/2022 & 35447948B, Exp 03/2023. b) Lots 35446318B, Exp 05/2022 & 35447947A, Exp 03/2023.
Why it was recalled
Subpotent
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
- a) 86,790 and b) 25,416 bottles
- Distribution pattern
- nationwide
Timeline
- Recall initiated
- 2021-12-16
- FDA classified
- 2021-12-23
- Posted by FDA
- 2021-12-29
- Terminated
- 2022-11-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0294-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.