Recalls / Class II
Class IID-1377-2012
Product
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.
- Affected lot / code info
- Lot # 2006500, Exp 08/31/12
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.
Recalling firm
- Firm
- Ben Venue Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 300 Northfield Rd, Bedford, Ohio 44146
Distribution
- Quantity
- 6,515 packs
- Distribution pattern
- Nationwide and Puerto Rico.
Timeline
- Recall initiated
- 2012-05-01
- FDA classified
- 2012-06-14
- Posted by FDA
- 2012-06-20
- Terminated
- 2013-08-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1377-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.