Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) b...
FDA Recall #D-0108-2018 — Class III — November 28, 2017
Product Description
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.
Recalling Firm
Teva Pharmaceuticals USA — North Wales, PA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
42,384 bottles
Distribution
Nationwide in the USA and Puerto Rico.
Code Information
Lot # 35433115A, Exp 01/18
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated