D-0108-2018 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 20, 2017
- Initiation Date
- November 28, 2017
- Termination Date
- July 3, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42,384 bottles
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.
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Code Information
Lot # 35433115A, Exp 01/18