Class I · High risk
Bleomycin for Injection
Presence of particulate matter: glass
Bleomycin for Injection
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Not elsewhere classified: Mislabeling
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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
Affected NDC
0143-9240-01
Compare with the code on your package — it is the most precise check available.
Drug: Bleomycin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Bleomycin NDC 00143-9240 |
SULFATE 15 [USP'U]/1 | Injection, Powder, Lyophilized, for Solution Intramuscular|intrapleural|intravenous|subcutaneous |
Hikma Pharmaceuticals USA Inc. | Rx |
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
- NDC code
- 0143-9240-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0771-2021 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Bleomycin recalls
See all
Class II · Moderate risk
Bleomycin 18 Units / 100 Ml Ns Ivpb
Lack of Assurance of Sterility
Class II · Moderate risk
Bleomycin Sulfate 1unit/ml
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Other recalls by Hikma Pharmaceuticals USA Inc.
All 2021 recalls
Class II · Moderate risk
Ramipril Capsules USP
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Class II · Moderate risk
Alendronate Sodium Oral Solution
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Class II · Moderate risk
Lorazepam Injection
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Class I · High risk
Acetaminophen Injection
Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.