Drug product
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toronto, Canada, M1B2K9, Manufactured For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454.
D-1205-2019
Product summary
- Event
- Event 82619
- Status
- Terminated
- Classification
- Class II
- Quantity
- 171,488 150 mL and 80 mL bottles
- Official record key
drug-enforcement:D-1205-2019
Official wording
Reason: Subpotent Product: assay results for Amoxicillin were below the specification limits.
Code information: Lots: (a) Lot # 35436769A, exp. date 05/2019; 35438389A, 35438390A, exp. date 01/2020; 35440838A, exp. date 10/2020; (b) 35437491A, 35443574B, exp. date 09/2021
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent