Status
Terminated
Drug Enforcement D-1377-2012
Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.
Classification
Class II
Report Date
June 20, 2012
Termination Date
August 21, 2013
Product Information
- Product description
- Octreotide Acetate Injection, 50 mcg/mL (0.05 mg/mL), 1 mL single dose vials, packaged in 10 x 1 mL single dose vials per pack, Rx only, Manufactured for: Bedford Laboratories, Bedford, OH 44146; Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146; NDC 55390-160-10; UPC 3 55390-160-10 1.
- Product quantity
- 6,515 packs
- Reason for recall
- Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico.
Location & Firm
- Recalling firm
- Ben Venue Laboratories Inc
- Address
-
300 Northfield Rd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1377-2012
- Event ID
- 61802
- Recall initiation date
- May 1, 2012
- Center classification date
- June 14, 2012
- Code info
- Lot # 2006500, Exp 08/31/12
- More code info
- —