Drug 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.
D-0108-2018
Product summary
- Event
- Event 78641
- Status
- Terminated
- Classification
- Class III
- Quantity
- 42,384 bottles
- Official record key
drug-enforcement:D-0108-2018
Official wording
Reason: Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Code information: Lot # 35433115A, Exp 01/18
Distribution pattern: Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Potency or specification failure
out of specification