Drug and pharmaceutical recalls
17622 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2024-12-11FDA-DrugMidlab IncorporatedClass IIArray Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE, WYOMING, MI 49509
cGMP Deviations: Out of specification results for micro in hand soap products.
- 2024-12-11FDA-DrugMidlab IncorporatedClass IIboardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufactured for Essendant Co., One Parkway North, Deerfield, IL 60015
cGMP Deviations: Out of specification results for micro in hand soap products.
- 2024-12-11FDA-DrugMidlab IncorporatedClass IIMAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutional Use Only, MIDLAB 140 Private Brand Way, Athens, TN 37303
cGMP Deviations: Out of specification results for micro in hand soap products.
- 2024-12-11FDA-DrugBoulla LLCClass IZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
- 2024-12-11FDA-DrugBoulla LLCClass IZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
- 2024-12-11FDA-DrugBoulla LLCClass IPeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
- 2024-12-11FDA-DrugBoulla LLCClass IVitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA www.vitalityxtra.com
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
- 2024-12-11FDA-DrugAmerican Regent, Inc.Class IIVenofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, American Regent, Inc. Shirley, NY 11967, NDC: 0517-2340-01 (vial), NDC: 0517-2340-10 (10 x 5 mL/vial cartons), NDC: 0517-2340-25 (25 x 5 mL/vial cartons).
Presence of Particulate Matter: Potential for glass delamination from the vials.
- 2024-12-11FDA-DrugAmerican Regent, Inc.Class IIVenofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-530-01 (vial), NDC: 49230-530-10 (10 x 2.5mL/vial cartons), NDC: 49230-530-25 (25 x 2.5mL/vial cartons).
Presence of Particulate Matter: Potential for glass delamination from the vials.
- 2024-12-11FDA-DrugAmerican Regent, Inc.Class IIVenofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (25 x 5 mL/vial cartons).
Presence of Particulate Matter: Potential for glass delamination from the vials.
- 2024-12-11FDA-DrugAurobindo Pharma USA IncClass IICinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC 65862-833-30 90 mg - 500 Tablets - NDC 65862-833-05
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- 2024-12-11FDA-DrugAurobindo Pharma USA IncClass IICinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- 2024-12-11FDA-DrugAurobindo Pharma USA IncClass IICinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- 2024-12-11FDA-DrugACCORD HEALTHCARE, INC.Class IILevothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-449-17
Subpotent drug
- 2024-12-04FDA-DrugJR WatkinsClass IICooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, Oakland CA 94612 UPC 8 56294 00878 5, NDC 72342-100-05
cGMP Deviations
- 2024-12-04FDA-DrugNeogen CorporationClass IILICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. (3785.4 mL mL) per jug, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53247-124-02
CGMP violations.
- 2024-12-04FDA-DrugNeogen CorporationClass IILICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53427-124-01
CGMP violations.
- 2024-12-04FDA-DrugUnexo Life Sciences Private LimitedClass IIPARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.025%, 6 patches per box, Distributed by: Pharmadel LLC, Georgetown, DE 19947 NDC 55758-039-01, UPC 8 59424 00433 6
cGMP Deviations
- 2024-12-04FDA-DrugUnexo Life Sciences Private LimitedClass IICHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky Bonsai, San Francisco, CA UPC 8 60006 57564 9
cGMP Deviations
- 2024-12-04FDA-DrugUnexo Life Sciences Private LimitedClass IIJR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Distributed By: J.R. Watkins, LLC, Oakland, CA 94612 UPC 8 56294 00878 5
cGMP Deviations
- 2024-12-04FDA-DrugUnexo Life Sciences Private LimitedClass IILILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87099 48212 1) and 10 patches per box (UPC 7 87099 48211 4), Distributed by: Lilas Wellness, Inc., Beaverton, Oregon 97008-7105
cGMP Deviations
- 2024-12-04FDA-DrugUnexo Life Sciences Private LimitedClass IIEQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH Lidocaine 4% Topical Anesthetic, 6 patches per box PATCHES, LIDOCAINE 4%, Distributed by: Walmart Inc., Bentonville, AR 72716 NDC 79903-106-06
cGMP Deviations
- 2024-12-04FDA-DrugUnexo Life Sciences Private LimitedClass IIHealthWise PERIOD PATCH Menstrual Pain Relief, Menthol 10%, 10 patches per box, Manufactured for Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-947-10, UPC 8 45717 01072 6
cGMP Deviations
- 2024-12-04FDA-DrugUnexo Life Sciences Private LimitedClass IITHERACARE Cold Hot Medicated Patch, Menthol 5%, 5 patches per box, Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-954-05, UPC 8 45717 00818 1
cGMP Deviations
- 2024-12-04FDA-DrugUnexo Life Sciences Private LimitedClass IITHERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24, UPC 8 45717 00878 5) and b) 6 patches (NDC 71101-001-06, UPC 8 45717 01056 6), Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031
cGMP Deviations
- 2024-12-04FDA-DrugUnexo Life Sciences Private LimitedClass IIABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a) 1 patch (UPC 8 89476 41251 3) and b) 6 patches (UPC 8 89476 41306 0), Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402
cGMP Deviations
- 2024-12-04FDA-DrugUnexo Life Sciences Private LimitedClass IIABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distributed By: Absorbine Jr. LLC, Chattanooga, TN 37402 UPC 8 89476 41318 3, UPC 8 89476 41336 7
cGMP Deviations
- 2024-12-04FDA-DrugUnexo Life Sciences Private LimitedClass IIABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, 1 extra large patch per box, Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402 UPC 8 89476 41218 6, UPC 8 89476 41236 0
cGMP Deviations
- 2024-11-27FDA-DrugEvaric Pharmaceuticals Inc.Class IILisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by: Walmart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, NDC# 68645-610-90.
Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.
- 2024-11-27FDA-DrugSafecor Health, LLCClass IIDocusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
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