Why it was recalled
Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.
Product description
Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, packaged in 10 x 1 mL single use vials per pack, Rx only, Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146; Manufactured for: Bedford Laboratories, Bedford, OH 44146, NDC 55390-138-01; UPC 3 55390-138-01 8.
Lot numbers, UPCs & expiration codes
Lot #1856177, Exp 06/30/13
Where it was sold
Nationwide and Puerto Rico.
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-1376-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 1, 2012
- FDA report date
- Jun 20, 2012
- Quantity
- 11,161 packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ben Venue Laboratories Inc
Original FDA data
Every field from FDA enforcement report D-1376-2012, exactly as published.
Show all FDA fields
- City
- Bedford
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 61802
- Address
- 300 Northfield Rd
- Code information
- Lot #1856177, Exp 06/30/13
- Postal code
- 44146
- Report date
- Jun 20, 2012
- Product type
- Drugs
- Recall number
- D-1376-2012
- Classification
- Class II
- Recalling firm
- Ben Venue Laboratories Inc
- Product quantity
- 11,161 packs
- Termination date
- Aug 21, 2013
- Reason for recall
- Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, packaged in 10 x 1 mL single use vials per pack, Rx only, Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146; Manufactured for: Bedford Laboratories, Bedford, OH 44146, NDC 55390-138-01; UPC 3 55390-138-01 8.
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- May 1, 2012
- Initial firm notification
- Letter
- Center classification date
- Jun 14, 2012