Class III
Terminated
Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454; NDC 0093-4125-73.
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- November 28, 2017
- Posted
- December 20, 2017
- Recall Number
- D-0108-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 42,384 bottles
- Firm Location
- North Wales, PA, United States
Reason for Recall
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Distribution
Nationwide in the USA and Puerto Rico.
Lot / Code Info
Lot # 35433115A, Exp 01/18
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