FDA Drug recall D-0480-2024
Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA…
- FDA Drug
- Class III
- completed
- Published 2024-05-08
On 2024-05-08 the FDA classified a Class III recall of Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA… by Hikma Injectables Usa, citing labeling: Wrong Barcode.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0480-2024 |
| Classification | Class III |
| Status | completed |
| Initiated | 2024-04-30 |
| Published | 2024-05-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hikma Injectables Usa |
| Distribution | US |
Product
Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05
Reason
Labeling: Wrong Barcode
Identifiers
| code_info | Lot #: CH0324001, Exp. Date 3/4/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0480-2024%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.