D-1205-2019 Class II Terminated
FDA drug recall D-1205-2019 was initiated by Teva Pharmaceuticals USA on April 12, 2019 and is designated Class II. Reason for recall: Subpotent Product: assay results for Amoxicillin were below the specification limits. The recall status is terminated (terminated July 8, 2020). Affected quantity: 171,488 150 mL and 80 mL bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 24, 2019
- Initiation Date
- April 12, 2019
- Termination Date
- July 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 171,488 150 mL and 80 mL bottles
Product Description
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.
Reason for Recall
Subpotent Product: assay results for Amoxicillin were below the specification limits.
Distribution Pattern
Nationwide in the USA and Puerto Rico
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