Class II · Moderate risk Terminated
Cytarabine 128 MG/250 ML D5W IVPB; Cytarabine 20 MG / 1 ML SQ SYRINGE Cytarabine 70 MG QS 6 ML PF NS SYRINGE; Cytarabine 100 MG…
Reason Lack of Assurance of Sterility
CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
What was recalled
CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only, Distributed by Bedford Laboratories, Bedford, OH 44146, Manufactured by Ben Venue Labs, Inc., Bedford, OH 44146, NDC 55390-808-01
- Recalling firm
- Ben Venue Laboratories Inc
- NDC code
- 55390-808-01
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1543-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Cytarabine recalls
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Class I · High risk Terminated
Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per carton…
Reason Presence of Particulate Matter
Class II · Moderate risk Terminated
Cytarabine Injection, 20 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc…
Reason The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to…
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