FDAJuly 15, 2022drug
Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
What to do
FDA enforcement status: Terminated
Brands named
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Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCOutdoor Master Children's and Youth Helmets Recalled Due to Risk of Serious Injury or Death from Head Injury; Violates Mandatory Standard for Bicycle Helmets; Sold and Imported by Outdoor Master2025-11-26
- FDACommon Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 087342022-07-15
- FDAAvant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 522532022-07-15
- FDAProtect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.2022-07-15
- FDAAvant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance Free, Manufactured for B4 Brands, Lisbon, Iowa 622532022-07-15
- FDAProtect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 336062022-07-15
- FDAMEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit with Sterile Gown/Hand Towel/CSR Wrap and boxes of 18 Gowns.2017-06-01
- FDA7-ELEVEN FRESH TO GO SUGAR COOKIE WITH M&M CHOCOLATE CANDY, 2 pieces, NET WT. 4 OZ. The affected cookies are packed in a clear, plastic film, two cookies per package.2016-04-22
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