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Every FDA drug enforcement recall Public Health Trace has on record, republished from
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Alerts for current, active recalls alongside outbreaks and advisories.
Drug recall information is sourced from the FDA's structured openFDA Enforcement
Reports. Newly announced recalls may appear on FDA.gov before they become available in
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Filters
Showing 6,001–6,020 of 17,964 drug recalls
Drug RecallTerminatedHistorical recordClass III
Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by Allergan, Irvine, CA 92612, NDC 0023-4965-02
by Allergan PLC
Reason
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distributed by Polarized, LLC, Produced by Eskbiochem SA de CV, Mexico Japon 50, Celaya, Gto., Mexico, 38010. UPC 8 60003 63391 5.
by UVT INC
Reason
Chemical Contamination: Product contains undeclared methanol.
Recall initiated
June 22, 2020
Reported by FDA
August 5, 2020
Distribution
Distributed to two wholesalers in FL who may have further distributed Nationwide in the USA.
Walker Hand Sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70%, 32 oz and 16 oz, Topical Solution, Walker Emulsions Inc., 4401 SE Johnson Creek Blvd., Portland, OR 97222, NDC 74940-0415-1
by WALKER EMULSIONS INC
Reason
Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.
Recall initiated
June 3, 2020
Reported by FDA
July 29, 2020
Distribution
US Distribution: Product distributed to sister plant site located in SC, and one donation made to consignee located in OR. Majority of hand sanitizer shipped to Canada (Health Canada has already received consignee information and classified the recall).
Walker Emulsions Hand Sanitizer (60%), Non-Sterile Solution, Alcohol Antiseptic 60%, 1 Gallon, Topical Solution, Walker Emulsions Inc., 4401 SE Johnson Creek Blvd., Portland, OR 97222, NDC 74940-0415-1
by WALKER EMULSIONS INC
Reason
Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.
Recall initiated
June 3, 2020
Reported by FDA
July 29, 2020
Distribution
US Distribution: Product distributed to sister plant site located in SC, and one donation made to consignee located in OR. Majority of hand sanitizer shipped to Canada (Health Canada has already received consignee information and classified the recall).
Mystic Shield PROTECTION, ALCOHOL ANTISEPTIC 70%, Topical Solution, Antiseptic Hand Rub, Non-sterile Solution, Extra strength Formula*, 8.45 fl. oz. (250 ml) bottle, Labeled with green or blue labels, Manufactured by Mystic Intl S.A. de C.V. UPC barcode: 7 87790 33952 6
by Transliquid Technologies, LLC
Reason
Chemical Contamination: Presence of Undeclared Methanol
Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use Only After Dilution, Distributed by HF Acquisition Co, LLC, Mukilteo, WA 98275, NDC 63323-739-12
by HF Acquisition Co. LLC
Reason
TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
Recall initiated
June 17, 2020
Reported by FDA
July 29, 2020
Distribution
The vials were distributed to one consignee located in CT.
Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047; NDC 63323-972-10
by Fresenius Kabi USA, LLC
Reason
Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.
Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc., 245 First Street Suite 1400, Cambridge, MA 02142, NDC: 59922-631-01.
by Keryx Biopharmaceuticals, Inc.
Reason
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
