Product: 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.
Reason for recall: Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Recall initiated: 20171128
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated