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Every FDA drug enforcement recall Public Health Trace has on record, republished from
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Showing 4,981–5,000 of 17,937 drug recalls
Drug RecallTerminatedHistorical recordClass III
Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago, IL 60631. NDC 71288-408-21
Kroger 70% Isopropyl Alcohol First Aid Antiseptic 32 FL OZ (1 QT) 946 mL 5 Dist. By The Kroger Co., Cincinnati, Ohio 45202 NDC 30142-810-45, UPC 0 11110 37049
by Vi-Jon, Inc.
Reason
Labeling: Label Mix-Up.The recall has been initiated after receiving one complaint about incorrect labeling.The primary label on the front and back label on some of the bottles have 70% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces
Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles, Distributed by: Asimex International LLC, 9100 S Dadeland Blvd, Ste 912, Miami, FL 33156, COUNTRY OF ORIGIN: MEXICO.
by Grupo Asimex de Mexico SA de CV
Reason
CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Recall initiated
August 14, 2020
Reported by FDA
September 22, 2021
Distribution
Distributor in FL who further distributed Nationwide in the USA
Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles, Distributed by: Asimex International LLC, 9100 S Dadeland Blvd, Ste 912, Miami, FL 33156, COUNTRY OF ORIGIN: MEXICO.
by Grupo Asimex de Mexico SA de CV
Reason
Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content.
Recall initiated
August 14, 2020
Reported by FDA
September 22, 2021
Distribution
Distributor in FL who further distributed Nationwide in the USA
HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6 lbs 14.2 oz) 1 gallon; Net Quantity (3785 mL), Manufactured by Soapdaddy LLC, 2401 E. 85th Street, Kansas City, MO 64131
by Charles Paint Research Inc
Reason
CGMP Deviations: Product contains acetaldehyde and acetal above the allowable limits.
HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6 lbs 14.2 oz) 1 gallon; Net Quantity (3785 mL), Manufactured by Soapdaddy LLC, 2401 E. 85th Street, Kansas City, MO 64131
by Charles Paint Research Inc
Reason
CGMP Deviations: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits.
aulief (Organic Camphor 3.00% Organic Menthol 5.00%), topical pain relief, packaged as a) 3.2 oz (90.7g) tube UPC 6 87806 30003 1 NDC 76305-302-01 ; b) 7.0 oz (198.5g) tube, UPC 6 87806 30007 9, NDC 76305-302-02; c) 16 oz (453.6g)Bottle w/ Pump, UPC 6 87806 30016 1, NDC 76305-302-03; Distributed by: CHINA-GEL LLC, Arlington Heights, IL 60005,
by China Gel Inc
Reason
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Recall initiated
March 10, 2021
Reported by FDA
September 8, 2021
Distribution
Distributed Nationwide in the USA as well as Australia, Canada, France, Germany, Ireland, Norway, Turks & Caicos, Republic of Maldives, Russia, Singapore, Switzerland, United Kingdom
CHINA-GEL WHITE (Camphor 3.00%, Menthol 5.00%), A TOPICAL PAIN RELIEVER, packaged in a) 2 oz(56.8g) Tube, 76305-301-13 ; b) 4 oz (113.5 g) jar, UPC 6 87806 20004 1, NDC 76305-301-02 ; c) 6 OZ (170 g) tube, UPC 6 87806 20006 5, NDC 76305-301-03; d) 8 oz (226.8 g) Jar, UPC 6 87806 20008 9, NDC 76305-301-04; e) 16 oz ( 453.6 g) Bottle w/ Pump, UPC 6 87806 20016 4, NDC 76305-301-05; f) 120 oz (3.78L) gallon, UPC 6 87806 20128 4, NDC 76305-301-06: Distributed by: CHINA-GEL LLC, Arlington Heights, IL 60005,
by China Gel Inc
Reason
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Recall initiated
March 10, 2021
Reported by FDA
September 8, 2021
Distribution
Distributed Nationwide in the USA as well as Australia, Canada, France, Germany, Ireland, Norway, Turks & Caicos, Republic of Maldives, Russia, Singapore, Switzerland, United Kingdom
CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A TOPICAL PAIN RELIEVER, packaged as a) 2 OZ (56.8g) tube, NDC 76305-300-13; b) 4 OZ (113.5g) jar, UPC 6 87806 10004 2, NDC 76305-300-02; c) 6 OZ (170 g) tube, UPC 6 87806 10006 2, NDC 76305-300-03; d) 8 OZ (226.8g) jar, UPC 6 87806 10008 2, NDC 76305-300-04; e) 16 OZ (453.6g), Bottle w/ Pump, UPC 6 87806 10016 7, NDC 76305-300-03; f) 128 OZ (3.78L) Gallon, UPC 6 87806 10128 7, NDC 76305-300-06; Distributed by: CHINA-GEL LLC, Arlington Heights, IL 60005,
by China Gel Inc
Reason
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Recall initiated
March 10, 2021
Reported by FDA
September 8, 2021
Distribution
Distributed Nationwide in the USA as well as Australia, Canada, France, Germany, Ireland, Norway, Turks & Caicos, Republic of Maldives, Russia, Singapore, Switzerland, United Kingdom
Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-062-35
by Akorn, Inc.
Reason
Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.
Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-008-14.
by Teligent Pharma, Inc.
Reason
Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.
MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 Fl OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200. Distributed by SBL Brands, LLC Las Vegas, NV 89119 UPC: 6 76753 00420 8 ,
by Global Sanitizers LLC
Reason
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Brands, LLC Las Vegas, NV 89119. UPC: 6 76753 00359 1 ,
by Global Sanitizers LLC
Reason
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
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.
