FDA-Drug2012-06-20Class II

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.

Ben Venue Laboratories Inc
Hazard

Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.

Sold states
Nationwide and Puerto Rico.
Affected count
6,515 packs
Manufactured in
300 Northfield Rd, Bedford, OH, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1377-2012

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