FDA Recall
Terminated
Historical recordClass I
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost with tea tree oil (70% ethyl alcohol), 33.8 fl oz / 1 L bottle, Distributed in USA and Canada by: 4e Brands 4e Brands Northamerica LLC. 17806 IH-10W, Suite 300, San Antonio, Texas, 78257. Made in Mexico. UPC 8 14266 02374 7
by 4e Brands North America, Llc
- Reason
- Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 6 b) 17 fl oz / 503 ml bottle with blue cap or pump bottle, UPC 8 14266 02409 6 c) 33.8 fl oz / 1 L straight or curved bottle, UPC 8 14266 02369 3. Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico.
by 4e Brands North America, Llc
- Reason
- Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcohol), 33.8 FL OZ (1 L) bottle, Distributed by Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mexico. UPC 0 32251 49935 7
by 4e Brands North America, Llc
- Reason
- CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49070 4 b) 10 fL oz / 295 ml bottle, UPC 6 39277 49070 4, Distributed by Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mexico
by 4e Brands North America, Llc
- Reason
- CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ASSURED Instant Hand Sanitizer Vitamin E and Aloe, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49069 8 b) 10 fL oz / 296 ml bottle, UPC 6 39277 49069 8, Distributed by Geenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mexico
by 4e Brands North America, Llc
- Reason
- CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/v), 3.4 fl. oz./100 mL bottle, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico. UPC 8 14266 02358 7
by 4e Brands North America, Llc
- Reason
- CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 6 b) 7.5 fl oz / 221 ml bottle, UPC 8 14266 02362 4 c) 15.2 fl oz (450 ml) bottle, UPC 8 14266 02392 1, d) 17 fl oz / 503 ml bottle with blue cap or pump bottle, UPC 8 14266 02409 6, e) 18 fl oz / 532 ml bottle, UPC 8 14266 02391 4, f) 33.8 fl oz / 1 L straight or curved bottle, UPC 8 14266 02369 3 g) 70 fl oz / 2.07L bottle, UPC 8 14266 02367 9 h) 1.05 GAL / 4L bottle, UPC 8 14266 02368 6; Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico.
by 4e Brands North America, Llc
- Reason
- CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
blumen ADVANCED HAND SANITIZER, 70% ALCOHOL CONTENT, (70% ethyl alcohol), packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4 b) 7.5 fl. oz./221 ml bottle, UPC 8 14266 02362 4 b) 33.8 fl. oz./1L bottle, UPC 8 14266 02369 3, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico.
by 4e Brands North America, Llc
- Reason
- CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost with Tea Tree Oil, (70% ethyl alcohol), Packaged as a) 18 fl oz / 532 ml bottle, UPC 8 14266 02408 9 b) 33.8 fl oz / 1L bottle, UPC 8 14266 02374 7, Distributed in USA and Canada BY: 4e Brands Northamerica LLC. 17806 IH-10W, Suite 300, San Antonio, Texas, 78257. Made in Mexico.
by 4e Brands North America, Llc
- Reason
- CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by: 3M Drug Delivery Systems, 19901 Nordhoff street, Northridge, CA 91324 USA, Manufactured for: Teva Pharmaceuticals USA Inc., North Wales, PA 19454, carton NDC: 0093-3656-40, patch NDC: 0093-3656-21.
by Teva Pharmaceuticals USA
- Reason
- Failed Stability Specifications: Below specification result for buprenorphine release rate.
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz. For Oral Use Only Rx Only Manufactured by: Sun Pharmaceuticals Industries Limited Mohali, India Distributed by: Sun Pharmaceuticals Industries, Inc. Cranbury, NJ 08512 NDC 10631-019-17
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Strides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg) 100 Tablets Rx Only Manufactured by: Strides Pharma Science Limited Bengaluru -562106 India Distributed by: Strides Pharma Inc., East Brunswick NJ 08816 NDC 64380-860-06
by Strides Inc.
- Reason
- Failed Dissolution Specifications
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
EAGLE FAMILY FOODS GROUP LLC
- Product
- Nice! Organic White Cheddar Popcorn, 4.5 oz. bag, UPC 049022…
- Reason
- Foreign material, pieces of glass may be in the product
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
EAGLE FAMILY FOODS GROUP LLC
- Product
- Nature's Promise Organic Lightly Salted Popcorn, 6 oz. bag,…
- Reason
- Foreign material, pieces of glass may be in the product
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
EAGLE FAMILY FOODS GROUP LLC
- Product
- Cretors Organic Extra Virgin Olive Oil Popcorn, 4.4 oz. bag,…
- Reason
- Foreign material, pieces of glass may be in the product
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
EAGLE FAMILY FOODS GROUP LLC
- Product
- 365 Everyday Value Organic Classic Salted Popcorn, 6 oz. bag…
- Reason
- Foreign material, pieces of glass may be in the product
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
EAGLE FAMILY FOODS GROUP LLC
- Product
- 365 Whole Foods Market Organic Reduced fat &Sodium Popcorn,…
- Reason
- Foreign material, pieces of glass may be in the product
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
EAGLE FAMILY FOODS GROUP LLC
- Product
- 365 Whole Foods Market Organic White Cheddar Popcorn, 4 oz.…
- Reason
- Foreign material, pieces of glass may be in the product
- Published
- October 7, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling.
by The Protein Shoppe
- Reason
- Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug fro which the safety and efficacy have not been established and therefore subject to recall.
- Published
- September 30, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations, Manufactured by: Catalent Pharma Solutions, 160 N Pharma Drive, Morrisville, NC 27560, Distributed by: Perrigo, Allegan, MI 49010 NDC 45802-088-01
by Perrigo Company PLC
- Reason
- Defective Delivery System: Sustained trend of failure to dispense complaints.
- Published
- September 30, 2020
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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