FDA Drug recall D-0392-2024
Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, ND…
- FDA Drug
- Class II
- ongoing
- Published 2024-03-27
On 2024-03-27 the FDA classified a Class II recall of Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, ND… by Hikma Pharmaceuticals Usa, citing the filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0392-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-12 |
| Published | 2024-03-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hikma Pharmaceuticals Usa |
| Distribution | US |
Product
Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01
Reason
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Identifiers
| ndc | 0641-6039-01 |
|---|---|
| ndc | 0641-6040-01 |
| code_info | Lot #: 052001, 052003, Exp. Date 11/2024; 023012, 023014, Exp. Date 08/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Drug · Class II · 2026-05-06 · Hikma Pharmaceuticals Usa - Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
FDA Drug · Class II · 2025-08-06 · Hikma Pharmaceuticals Usa - Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma…
FDA Drug · Class I · 2024-08-28 · Hikma Pharmaceuticals Usa - Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufac…
FDA Drug · Class II · 2023-05-24 · Hikma Pharmaceuticals Usa
All Hikma Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0392-2024%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.