Drug product
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73
D-0440-2017
Product summary
- Event
- Event 76038
- Status
- Terminated
- Classification
- Class II
- Quantity
- 133,601 bottles
- Official record key
drug-enforcement:D-0440-2017
Official wording
Reason: Subpotency: due to a low, out of specification test result for assay during stability testing.
Code information: Lot # 35432507A, 35434914A, 35435798A, 35437490A, Exp 9/19
Distribution pattern: United States and Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotency