FDA Drug recall D-0771-2021
Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GmbH Schiffgraben 23…
- FDA Drug
- Class III
- terminated
- Published 2021-09-01
On 2021-09-01 the FDA classified a Class III recall of Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GmbH Schiffgraben 23… by Hikma Pharmaceuticals Usa, citing labeling: Not elsewhere classified: Mislabeling.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0771-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-08-05 |
| Published | 2021-09-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hikma Pharmaceuticals Usa |
| Distribution | US |
Product
Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GmbH Schiffgraben 23, 38690 Gosfar, Germany Distributed by Hikma USA Inc. Berkeley Heights, NJ 07922, NDC 0143-9240-01
Reason
Labeling: Not elsewhere classified: Mislabeling
Identifiers
| ndc | 0143-9240-01 |
|---|---|
| ndc | 0143-9241-01 |
| code_info | BL0018 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class II · 2026-09-02 · Hikma Pharmaceuticals Usa - Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Be…
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 - Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, ND…
FDA Drug · Class II · 2024-03-27 · Hikma Pharmaceuticals Usa
All Hikma Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0771-2021%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.