FDA Drug recall D-0165-2024
AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED, Toronto, Canada M…
- FDA Drug
- Class II
- terminated
- Published 2024-01-03
On 2024-01-03 the FDA classified a Class II recall of AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED, Toronto, Canada M… by Cardinal Healthcare, citing CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0165-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-01-26 |
| Published | 2024-01-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cardinal Healthcare |
| Distribution | US |
Product
AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED, Toronto, Canada M1B 2K9; Manufactured For: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. NDC: 0093-4161-73
Reason
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Identifiers
| ndc | 0093-2263-01 |
|---|---|
| ndc | 0093-2264-01 |
| ndc | 0093-4160-76 |
| ndc | 0093-4160-78 |
| ndc | 0093-4160-73 |
| ndc | 0093-4155-79 |
| ndc | 0093-4155-73 |
| ndc | 0093-4155-80 |
| ndc | 0093-4161-76 |
| ndc | 0093-4161-78 |
| ndc | 0093-4161-73 |
| ndc | 0093-2267-01 |
| ndc | 0093-2268-01 |
| ndc | 0093-3107-01 |
| ndc | 0093-3107-05 |
| ndc | 0093-3109-53 |
| ndc | 0093-3109-05 |
| code_info | Batch 35447184A |
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-0165-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.