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Recall Observatory FDA recall evidence

Drug 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.

D-1377-2012

May 01, 2012

Class II

Product summary

Firm
Ben Venue Laboratories Inc
Event
Event 61802
Status
Terminated
Classification
Class II
Quantity
6,515 packs
Official record key
drug-enforcement:D-1377-2012

Official wording

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

Code information: Lot # 2006500, Exp 08/31/12

Distribution pattern: Nationwide and Puerto Rico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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