Class II
Terminated
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.
This recall has been terminated (originally issued April 24, 2019).
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- April 12, 2019
- Posted
- April 24, 2019
- Recall Number
- D-1205-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 171,488 150 mL and 80 mL bottles
- Firm Location
- North Wales, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Subpotent Product: assay results for Amoxicillin were below the specification limits.
Distribution
Nationwide in the USA and Puerto Rico
Lot / Code Info
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
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