FDA Drug recall D-0496-2024
Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, In…
- FDA Drug
- Class II
- terminated
- Published 2024-05-22
On 2024-05-22 the FDA classified a Class II recall of Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, In… by Lupin Pharmaceuticals, citing presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0496-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-04-24 |
| Published | 2024-05-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-723-04
Reason
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Identifiers
| ndc | 68180-722-20 |
|---|---|
| ndc | 68180-722-10 |
| ndc | 68180-722-04 |
| ndc | 68180-722-05 |
| ndc | 68180-723-20 |
| ndc | 68180-723-10 |
| ndc | 68180-723-04 |
| ndc | 68180-723-05 |
| code_info | Lot # F305442, Exp 8/30/2025 |
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-0496-2024%22
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