Hydrogen Peroxide Topical Solution USP, 3%, 16 FL OZ (1 PT) 473 mL bottle, packaged as a) Signatu...
FDA Drug Recall #D-1244-2022 — Class II — June 28, 2022
Recall Summary
| Recall Number | D-1244-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 28, 2022 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Vi-Jon, LLC |
| Location | Smyrna, TN |
| Product Type | Drugs |
| Quantity | 3,421,032 bottles |
Product Description
Hydrogen Peroxide Topical Solution USP, 3%, 16 FL OZ (1 PT) 473 mL bottle, packaged as a) Signature Care NDC 21130-871-43 UPC 3 21130-78060 1 Distributed By Better Living Brands LLC P.O. Box 99, Pleasanton, CA 94566-0009; b) Solimo UPC 8 42379 14781 4 Distributed By: Amazon.com Services, Inc. Seattle, WA 98109; c) QC Quality Choice UPC 6 35515 99466 9 Distributed by C.D.M.A., Inc. 43157 W 9 Mile Rd, Novi, MI; d) CVS Health UPC 0 50428 37591 4 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; e) Careone UPC 3 41520 31311 0 Distributed By: Foodhold U.S.A., LLC Landover, MD 20785; f) Market Basket UPC 0 49705 75280 7 Distributed By Demoulas Super Markets, Inc. 875 East Street, Tewksbury, MA 01876; g) Rexall UPC 0 72785 13848 3 Distributed By Old East Main Co. 100 Mission Ridge, Goodlettsville, TN 37072; h) HEB UPC 9 41220 25111 7 Distributed By: HEB San Antonio, TX 78204; i) Core Values UPC 0 79068 00707 8 Distributed by Liberty Procurement Co., Inc. Union, NJ 07083; j) Swan NDC 0869-0871-43 UPC 3 08694 70610 0 Distributed by Vi-Jon One Swan Drive, Smyrna, TN 37167; k) Cariba Care UPC 6 46702 05602 2 Distributed by: Cariba International P.O. Box 1208. Safety Harbor, Florida 34695; l) Kroger UPC 0 11110 79460 4 Distributed By The Kroger Co., Cincinnati, Ohio 45202; m) CVP Health UPC 7 61706 16314 6 Distributed By Salado Sales, Inc. Temple, TX 76503; n) Medline NDC 53329-981-06 UPC 0 80196 74870 2 Made in US with US and foreign components for Medline Industries, Inc., Northfield, IL 60093; o) Exchange Select UPC 6 14299 39968 6 Manufactured For Your Military Exchanges By: Vi-Jon 8515 Page Avenue, St. Louis, MO 63114; p) Premier Value UPC 8 40986 01021 7 Distributed by: Pharmacy Value Alliance LLC 407 East Lancaster Avenue Wayne, PA 19087; q) Publix UPC 0 41415 00973 8 Distributed By Publix Super Markets, Inc. 3300 Publix Corporate Parkway Lakeland, FL 33811; r) Being Well UPC 0 51933 13950 3 Distributed By: Moran Foods, LLC St. Ann, MO 63074; s) Medicare NPN 80016265 UPC 8 39748 00017 7 Manufactured by/Fabrique par: Vi-Jon Inc., Smyna, TN 37167; t) Swan NPN 80035214 UPC 0 72785 11239 1 Manufactured By: Vi-Jon, Inc. St. Louis, MO 63114; u) Equate NPN 80036214 UPC 6 28915 16613 3 Manufactured By: Vi-Jon, Inc. St. Louis, MO 63114; v) Iris UPC 61504-871-43 UPC 0 41512 12940 7 Distributed By: Amerifoods Trading Co. P.O. Box 512377, Los Angeles, CA 90051-0377; w) Equaline NDC 41163-871-43 UPC 0 41163 25134 2 Distributed by Supervalu Inc. Eden Prairie, MN 55344 USA; x) TopCare health UPC 0 36800 26711 4 Distributed By TopCo Associates LLC Elk Grove Village, IL 60007; y) Best Choice UPC 0 70038 20055 0 Distributed By: Valu Merchandisers, Co. 6000 Kansas Ave. Kansas City, KS 66106; z) Walgreens NDC 0363-0871-43 UPC 3 11917 20771 1 Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015; aa) Equate NDC 49035-871-43 UPC 6 81131 11871 2 Distributed By: Walmart, Inc., Bentonville, AR 72716
Reason for Recall
Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.
Distribution Pattern
Nationwide in the USA and Canada
Lot / Code Information
Lots: 0555123 Exp. 11/2023 ; 0556347 Exp. 01/2024 ; 0559888 Exp. 03/2024 ; 0546090 Exp. 09/2023 ; 0546364 Exp. 08/2023 ; 0554099 Exp. 11/2023 ; 0535281 Exp. 05/2023 ; 0538263 Exp. 07/2023 ; 0542015 Exp. 07/2023 ; 0550161 Exp. 10/2023 ; 0550164 Exp. 11/2023 ; 0556345 Exp. 01/2024 ; 0557214 Exp. 12/2023 ; 0557366 Exp. 01/2024 ; 0568635 Exp. 05/2024 ; 0556328 Exp. 11/2023 ; 0557465 Exp. 03/2024 ; 0566639 Exp. 03/2024 ; 0566835 Exp. 03/2024 ; 0538261 Exp. 06/2023 ; 0538264 Exp. 07/2023 ; 0541465 Exp. 07/2023 ; 0556809 Exp. 11/2023 ; 0566640 Exp. 03/2024 ; 0556351 Exp. 01/2024 ; 0563077 Exp. 02/2024 ; 0564653 Exp. 03/2024 ; 0565511 Exp. 04/2024 ; 0566646 Exp. 03/2024 ; 0532595 Exp. 04/2023
Other Recalls from Vi-Jon, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1173-2023 | Class III | Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGI... | Sep 5, 2023 |
| D-1509-2022 | Class I | Walgreens, Dye-Free, Magnesium Citrate, SALINE ... | Jul 15, 2022 |
| D-1503-2022 | Class I | Kroger, Magnesium Citrate SALINE LAXATIVE, Oral... | Jul 15, 2022 |
| D-1505-2022 | Class I | P, magnesium citrate SALINE LAXATIVE, Oral Solu... | Jul 15, 2022 |
| D-1501-2022 | Class I | equate Magnesium Citrate, SALINE LAXATIVE, (1.7... | Jul 15, 2022 |
Frequently Asked Questions
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.