Drug recall D-0108-2018
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.
Lots and codes
Lot # 35433115A, Exp 01/18
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, North Wales, PA
- Quantity
- 42,384 bottles
- Distribution
- Nationwide in the USA and Puerto Rico.
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 28, 2017
- Terminated
- July 3, 2018
Related products
- Penicillin V Potassium – drug information
- NDC 0093-4125 Penicillin V Potassium · Penicillin V Potassium 125 mg/5mL · Teva Pharmaceuticals USA, Inc.
- NDC 0093-1172 Penicillin V Potassium · Penicillin V Potassium 250 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0093-1174 Penicillin V Potassium · Penicillin V Potassium 500 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0093-4127 Penicillin V Potassium · Penicillin V Potassium 250 mg/5mL · Teva Pharmaceuticals USA, Inc.