FDADecember 11, 2014device
Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The dials in the Autopens are not working - the dial does not stay dialed, but springs right back to 0. As a result, the patient could not dial up a dose of medicine to deliver via an injection.
What to do
FDA enforcement status: Terminated
Brands named
owen mumfordowen
UPCs
38470380001408470380001
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAFHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and b)1 fl. oz./30ml tubes; Made in the USA for FarmHouse Fresh, 8797 CR 858 McKinney, Texas2026-03-03
- FDAHydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE, a)1 FL OZ/30ml; b) 2 FL OZ/60ml spray bottle; DIST BY HYDROPEPTIDE LLC, ISSAQUAH, WA 980272026-03-03
- FDASLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz - 21 mL and b) 1.5 fl. oz. - 44mL bottles, SANDRA LEE MD., Distributed by Skin PS Brands, Culver City, CA 90232.2026-03-03
- FDASLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl. oz - 15 mL bottles, Sandra Lee MD, Distributed by Skin PS Brands, Culver City, CA90232.2026-03-03
- FDAFLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 471472023-01-03
- FDAAero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 417342022-10-31
- FDAUnifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.2021-05-26
- FDAAutoject EI, REF AJ13102019-07-17
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