Why it was recalled
Presence of Particulate Matter
Product description
Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg Vials, lyophilized powder per carton, Rx Only, Mfr. By: Ben Venue Laboratories, Bedford, OH 44146: Mfg for: Bedford Labs, Bedford, OH 44146, NDC 55390-039-10.
Lot numbers, UPCs & expiration codes
Lot #2067134 Exp 5/31/2013, NDC 55390-039-10
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-1697-2012
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jun 26, 2012
- FDA report date
- Oct 3, 2012
- Quantity
- 797 boxes/10/20 mg vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ben Venue Laboratories Inc
Original FDA data
Every field from FDA enforcement report D-1697-2012, exactly as published.
Show all FDA fields
- City
- Bedford
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 62422
- Address
- 300 Northfield Rd
- Code information
- Lot #2067134 Exp 5/31/2013, NDC 55390-039-10
- Postal code
- 44146
- Report date
- Oct 3, 2012
- Product type
- Drugs
- Recall number
- D-1697-2012
- Classification
- Class I
- Recalling firm
- Ben Venue Laboratories Inc
- Product quantity
- 797 boxes/10/20 mg vials
- Termination date
- Feb 3, 2014
- Reason for recall
- Presence of Particulate Matter
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg Vials, lyophilized powder per carton, Rx Only, Mfr. By: Ben Venue Laboratories, Bedford, OH 44146: Mfg for: Bedford Labs, Bedford, OH 44146, NDC 55390-039-10.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 26, 2012
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Sep 26, 2012