Ben Venue Recalls Cytarabine for Injection Due to Sterility Concerns
Ben Venue Laboratories is recalling 7,172 vials of Cytarabine for Injection due to potential crimp defects that may affect sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
Ben Venue Laboratories Inc. is recalling 7,172 vials of CYTARAbine for Injection USP, 1 gram per vial. The product is distributed by Bedford Laboratories and is available nationwide. The recall involves two specific lots: Lot # 0161-13-2167551 (Expiration 07/14) and Lot # 0161-13-2176919 (Expiration 08/14).
The recall is being conducted due to a lack of assurance of sterility. Crimp defects identified during visual inspection could affect the container closure integrity, potentially compromising the sterility of the medication.
Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be quarantined and not administered. Patients who have already received the medication should contact their healthcare provider for guidance.
The recalled product
- Product
- 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
- Manufacturer
- Ben Venue Laboratories Inc
- Category
- Drug — Injectable Medication
- Affected units
- 7,172
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # 0161-13-2167551
- Exp. 07/14 Lot # 0161-13-2176919
- Exp. 08/14
Distribution
Distributed nationwide across the United States.
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