Why it was recalled
Labeling: Not elsewhere classified: Mislabeling
Product description
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
Lot numbers, UPCs & expiration codes
BL0018
Where it was sold
USA nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0771-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 5, 2021
- FDA report date
- Sep 1, 2021
- Quantity
- 1,152 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
Original FDA data
Every field from FDA enforcement report D-0771-2021, exactly as published.
Show all FDA fields
- City
- Cherry Hill
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88402
- Address
- 2 Esterbrook Ln
- Code information
- BL0018
- Postal code
- 08003-4002
- Report date
- Sep 1, 2021
- Product type
- Drugs
- Recall number
- D-0771-2021
- Classification
- Class III
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
- Product quantity
- 1,152 vials
- Termination date
- Jun 8, 2023
- Reason for recall
- Labeling: Not elsewhere classified: Mislabeling
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- USA nationwide
- Recall initiation date
- Aug 5, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 26, 2021