Drug and pharmaceutical recalls

17707 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2020-10-14FDA-DrugCalvin Scott & Company, Inc.Class II
Phentermine, 30 mg capsules, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-0597-10
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
2020-10-14FDA-DrugCalvin Scott & Company, Inc.Class II
Diethylpropion, 75 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1477-01
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
2020-10-14FDA-DrugCalvin Scott & Company, Inc.Class II
Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1475-01
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
2020-10-14FDA-DrugPD-Rx Pharmaceuticals, Inc.Class 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.
CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.
2020-10-07FDA-DrugAkorn, Inc.Class 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
CGMP Deviations
2020-10-07FDA-DrugpH-D Feminine HealthClass 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.
Marketed without an Approved NDA/ANDA.
2020-10-07FDA-DrugLegacy Pharmaceutical Packaging LLCClass 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
Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
2020-10-07FDA-DrugArbor Pharmaceuticals Inc.Class 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
Subpotent Drug
2020-10-07FDA-DrugVolu-Sol, Inc.Class 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
Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
2020-10-07FDA-DrugDirect RxClass 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
CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
2020-10-07FDA-Drug4e Brands North America, LlcClass 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.
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
2020-10-07FDA-Drug4e Brands North America, LlcClass 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
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
2020-10-07FDA-Drug4e Brands North America, LlcClass 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.
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
2020-10-07FDA-Drug4e Brands North America, LlcClass 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
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.
2020-10-07FDA-Drug4e Brands North America, LlcClass 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
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.
2020-10-07FDA-Drug4e Brands North America, LlcClass 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
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.
2020-10-07FDA-Drug4e Brands North America, LlcClass 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
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.
2020-10-07FDA-Drug4e Brands North America, LlcClass 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 /
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.
2020-10-07FDA-Drug4e Brands North America, LlcClass 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.
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.
2020-10-07FDA-Drug4e Brands North America, LlcClass 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.
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.
2020-10-07FDA-DrugP & L Developments, LLCClass 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.
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.
2020-10-07FDA-DrugTeva Pharmaceuticals USAClass 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.
Failed Stability Specifications: Below specification result for buprenorphine release rate.
2020-10-07FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass 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
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
2020-10-07FDA-DrugStrides Inc.Class II
Stop using Strides potassium chloride tablets
Failed Dissolution Specifications
2020-09-30FDA-DrugPreferred Pharmaceuticals, Inc.Class II
Nature-Throid, 1.5 Grain, (97.5 mg), (Thyroid U.S.P. 1.5 gr. (97.5mg)/Liothyronine (T3) 13.5mcg/Levothyroxine (T4) 57mcg, 90-count bottles, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-7605-09
CGMP Deviations
2020-09-30FDA-DrugPreferred Pharmaceuticals, Inc.Class II
Nature-Throid, 1 Grain, 65 mg (Thyroid U.S.P. 1 gr. (65mg)/Liothyronine (T3) 9mcg/Levothyroxine (T4) 38mcg, packaged in a) 90-count bottles (NDC 68788-7604-09), b) 100-count tablets (NDC 68788-7604-01), Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc.
CGMP Deviations
2020-09-30FDA-DrugPreferred Pharmaceuticals, Inc.Class II
Nature-Throid, 3/4 Grain (48.75 mg) Thyroid U.S.P. 3/4 gr. (48.75 mg)/Liothyronine (T3) 6.75mcg/Levothyroxine (T4) 28.5mcg, 90-count tablets, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-6860-09
CGMP Deviations
2020-09-30FDA-DrugPreferred Pharmaceuticals, Inc.Class II
Nature-Throid, 1/2 Grain, 32.5 mg (Thyroid U.S.P. 1/2 gr. (32.5 mg)/Liothyronine (T3) 4.5mcg/Levothyroxine (T4) 19mch, 100-count tablets, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-9283-01
CGMP Deviations
2020-09-30FDA-DrugAJR TRADING LLCClass II
bio aaa Alcohol en Gel Antibacterial, Alcohol al 70% Cont. Neto 480 ml bottle, Hecho en Mexico por: AAA Cosmetica S.A. DE C.V. Recursos Hidraulicos No. 1 Secc. A, Col La Loma Zona Industrial, Tlalnepantla de Baz C.P. 54060 Edo. Mexico. UPC 7 502272 12108 5
CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed lots of product.
2020-09-30FDA-DrugThe Protein ShoppeClass I
Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling.
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.

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