Drug Recall
Terminated
Historical recordClass II
Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), Liothyronine (T3) 9 mcg, Levothyroxine (T4) 38 mcg, 100 Tablets per bottle, Rx Only, Pkg By PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127, NDC 43063-819-01.
by PD-Rx Pharmaceuticals, Inc.
- Reason
- CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.
- Recall initiated
- September 17, 2020
- Reported by FDA
- October 14, 2020
- Distribution
- AZ, OK
View recall →
Drug Recall
Terminated
Historical recordClass II
Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsocket, RI 02895, NDC 59779-920-01
by Akorn, Inc.
- Reason
- CGMP Deviations
- Recall initiated
- September 3, 2020
- Reported by FDA
- October 7, 2020
- Distribution
- Nationwide in CA, IN, VA, NJ, NY, RI, FL, TX, MO, PA, MI, AL, TN, SC
View recall →
Drug Recall
Terminated
Historical recordClass II
pH-D Feminine Health Boric Acid Vaginal Suppositories, 24 vaginal suppositories per box, 600 mg each, pH-D Feminine Health, LLC Madison, TN 37115, UPC Code: 3 49597 00044 5.
by pH-D Feminine Health
- Reason
- Marketed without an Approved NDA/ANDA.
- Recall initiated
- September 2, 2020
- Reported by FDA
- October 7, 2020
- Distribution
- Nationwide in the U.S.
View recall →
Drug Recall
Terminated
Historical recordClass III
Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, Distributed by: Wal-Mart, Bentonville, AR 72716. NDC 68645-545-59
by Legacy Pharmaceutical Packaging LLC
- Reason
- Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
- Recall initiated
- September 24, 2020
- Reported by FDA
- October 7, 2020
- Distribution
- Walmart distribution centers in GA and AR
View recall →
Drug Recall
Terminated
Historical recordClass III
Nymalize (nimodipine) oral solution, 60 mg/20 mL, 12 Unit-Dose Cups and 12 Oral Syringes, 2 inner cartons per outer shipping carton, Rx Only, Distributed by arbor Atlanta, GA, NDC 24338-200-12
by Arbor Pharmaceuticals Inc.
- Reason
- Subpotent Drug
- Recall initiated
- September 16, 2020
- Reported by FDA
- October 7, 2020
- Distribution
- Nationwide within the United States
View recall →
Drug Recall
Terminated
Historical recordClass I
Volu-Sol Handrub Sanitizing Solution (Ethyl Alcohol, 69% v/v and Isopropyl Alcohol, 7.2% v/v) Topical Solution, 473 mL/ 16 fl oz bottle, Vou-Sol 5095 W 2100 S, Salt Lake City, UT 84120, NDC 74401-800-16
by Volu-Sol, Inc.
- Reason
- Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
- Recall initiated
- August 14, 2020
- Reported by FDA
- October 7, 2020
- Distribution
- Sold to one distributor located in CA and one hospital system located in UT.
View recall →
Drug Recall
Terminated
Historical recordClass II
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90
by Direct Rx
- Reason
- CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
- Recall initiated
- March 12, 2019
- Reported by FDA
- October 7, 2020
- Distribution
- FL
View recall →
Drug Recall
Terminated
Historical recordClass I
blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) 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, 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.
- Recall initiated
- July 11, 2020
- Reported by FDA
- October 7, 2020
- Distribution
- Distributed Nationwide in the USA
View recall →
Drug 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.
- Recall initiated
- July 11, 2020
- Reported by FDA
- October 7, 2020
- Distribution
- Distributed Nationwide in the USA
View recall →
Drug 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.
- Recall initiated
- July 11, 2020
- Reported by FDA
- October 7, 2020
- Distribution
- Distributed Nationwide in the USA
View recall →
Drug 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.
- Recall initiated
- July 11, 2020
- Reported by FDA
- October 7, 2020
- Distribution
- Distributed Nationwide in the USA
View recall →
Drug 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.
- Recall initiated
- July 11, 2020
- Reported by FDA
- October 7, 2020
- Distribution
- Distributed Nationwide in the USA
View recall →
Drug 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.
- Recall initiated
- July 11, 2020
- Reported by FDA
- October 7, 2020
- Distribution
- Distributed Nationwide in the USA
View recall →
Drug 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.
- Recall initiated
- July 11, 2020
- Reported by FDA
- October 7, 2020
- Distribution
- Distributed Nationwide in the USA
View recall →
Drug 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.
- Recall initiated
- July 11, 2020
- Reported by FDA
- October 7, 2020
- Distribution
- Distributed Nationwide in the USA
View recall →
Drug 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.
- Recall initiated
- July 11, 2020
- Reported by FDA
- October 7, 2020
- Distribution
- Distributed Nationwide in the USA
View recall →
Drug 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.
- Recall initiated
- July 11, 2020
- Reported by FDA
- October 7, 2020
- Distribution
- Distributed Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass III
Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-3328-3.
by P & L Developments, LLC
- Reason
- Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian market and is not part of the current approved drug labeling.
- Recall initiated
- September 9, 2020
- Reported by FDA
- October 7, 2020
- Distribution
- Recalled product was distributed to one retailer type in NY and MD who may have further distributed the product throughout the United States.
View recall →
Drug 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.
- Recall initiated
- September 4, 2020
- Reported by FDA
- October 7, 2020
- Distribution
- Nationwide in the U.S. and PR
View recall →
Drug 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.
- Recall initiated
- September 23, 2020
- Reported by FDA
- October 7, 2020
- Distribution
- Nationwide
View recall →
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.
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