FDA Drug recall D-0381-2023
Daptomycin for Injection 350 mg/vial, Rx only, Packaged as: a) Single-dose vial NDC 16729-434-05 UPC 3 16729 43405 8
- FDA Drug
- Class II
- terminated
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of Daptomycin for Injection 350 mg/vial, Rx only, Packaged as: a) Single-dose vial NDC 16729-434-05 UPC 3 16729 43405 8 by Accord Healthcare, citing CGMP Deviations: recalling drug products following an FDA inspection.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0381-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-02-07 |
| Published | 2023-03-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Accord Healthcare |
| Distribution | PR |
Product
Daptomycin for Injection 350 mg/vial, Rx only, Packaged as: a) Single-dose vial NDC 16729-434-05 UPC 3 16729 43405 8; b) 10 Single-dose vials NDC 16729-434-45 UPC 3 16729 43445 4 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Identifiers
| upc | 316729434058 |
|---|---|
| upc | 316729434454 |
| ndc | 16729-434-05 |
| ndc | 16729-434-45 |
| code_info | Batches: a) R2101274, Exp. Date 9/30/2023; R2200161, Exp. Date 1/31/2025; R2200506, Exp. Date 1/31/2025; R2200697, Exp.…Batches: a) R2101274, Exp. Date 9/30/2023; R2200161, Exp. Date 1/31/2025; R2200506, Exp. Date 1/31/2025; R2200697, Exp. Date 4/30/2025; R2201107, Exp. Date 7/31/2025; b) R2101471, Exp. Date 9/30/2023; R2200588, Exp. Date 4/30/2025; R2201333, Exp. Date 7/31/2025; R2201361, Exp. Date 8/31/2025; |
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-0381-2023%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.