Why it was recalled
Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # 0161-13-2167551; Exp. 07/14 Lot # 0161-13-2176919; Exp. 08/14
Where it was sold
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-1543-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 31, 2014
- FDA report date
- Aug 27, 2014
- Quantity
- 7172 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ben Venue Laboratories Inc
Original FDA data
Every field from FDA enforcement report D-1543-2014, exactly as published.
Show all FDA fields
- City
- Bedford
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 68800
- Address
- 300 Northfield Rd
- Code information
- Lot # 0161-13-2167551; Exp. 07/14 Lot # 0161-13-2176919; Exp. 08/14
- Postal code
- 44146-4650
- Report date
- Aug 27, 2014
- Product type
- Drugs
- Recall number
- D-1543-2014
- Classification
- Class II
- Recalling firm
- Ben Venue Laboratories Inc
- Product quantity
- 7172 vials
- Termination date
- Dec 2, 2014
- Reason for recall
- Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 31, 2014
- Initial firm notification
- Letter
- Center classification date
- Aug 18, 2014