Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake Forest, IL…
PFIZER · Presence of particulate matter: glass
- Status
- Ongoing
- City
- New York
- State
- NY
- Country
- United States
- Classification
- Class I
- Product type
- Drugs
- Event ID
- 93693
- Recalling firm
- PFIZER
- Address 1
- 66 Hudson St
- Address 2
- N/A
- Postal code
- 10013
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Press Release
- Distribution pattern
- Nationwide in the USA, Netherlands and Libya
- Recall number
- D-0261-2024
- Product quantity
- 3,546 vials
- Reason for recall
- Presence of particulate matter: glass
- Recall initiation date
- 20231221
- Center classification date
- 20240125
- Report date
- 20240131
- Code info
- Lot #: BL12206A, Exp date 06/30/2024
- Product description
Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake Forest, IL 68045, NDC 61703-332-18
- Harmonized identifiers (openFDA)
- Application number
- ANDA065031
- Brand name
- BLEOMYCIN
- Generic name
- BLEOMYCIN
- Manufacturer name
- Hospira, Inc.
- Product NDC
- 61703-323, 61703-332
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAMUSCULAR, INTRAPLEURAL, INTRAVENOUS, SUBCUTANEOUS
- Substance name
- BLEOMYCIN SULFATE
- RxCUI
- 1726673, 1726676
- SPL ID
- 6615dbd2-3bb4-40b5-8599-aa46bc0bc488
- SPL set ID
- 905e0984-2ce3-481c-b1a0-0ef0a616479a
- Package NDC
- 61703-323-22, 61703-332-18
- Is original packager
- true
- UNII
- 7DP3NTV15T