Drug product
Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76
D-1470-2016
Product summary
- Event
- Event 74540
- Status
- Terminated
- Classification
- Class II
- Quantity
- 53,328 bottles
- Official record key
drug-enforcement:D-1470-2016
Official wording
Reason: Superpotent drug: Out of specification test result for assay during stability testing.
Code information: Lot # 35434158A, Exp 6/17
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Superpotent