FDANovember 6, 2017device
Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.
What to do
FDA enforcement status: Terminated
Brands named
owen mumfordowen
UPCs
384701150012
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
- FDAPetfine Auto Injector, REF 3310VET2019-07-17
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