FDA Drug recall D-1205-2019
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),…
- FDA Drug
- Class II
- terminated
- Published 2019-04-24
On 2019-04-24 the FDA classified a Class II recall of 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),… by Teva Pharmaceuticals Usa, citing subpotent Product: assay results for Amoxicillin were below the specification limits.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1205-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-12 |
| Published | 2019-04-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
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.
Reason
Subpotent Product: assay results for Amoxicillin were below the specification limits.
Identifiers
| 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1205-2019%22
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