FDA Drug Recalls

Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 41167-0310-1 41167-0310-2 41167-0310-3 41167-0310-4 41167-0310-6 41167-0310-7 41167-0310-8

Sanofi-Aventis U.S. LLC

CGMP Deviations: Presence of NDMA impurity detected in product.

Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0121-01, 0597-0121-06, 0597-0121-08, 0597-0121-09, 0597-0121-11, 0597-0121-24, 0597-0121-38, 0597-0121-50, 0597-0121-64, 0597-0121-66, 0597-0121-68, 0597-0121-78, 0597-0121-80, 0597-0121-82, 0597-0121-85, 0597-0121-90, 0597-0121-94.

Sanofi-Aventis U.S. LLC

CGMP Deviations: Presence of NDMA impurity detected in product.

October 22, 2019 · Drug

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Class IIITerminated

Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-2580-8

Apotex Inc.

Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.

Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's: 41167-0320-1 41167-0320-2 41167-0320-3 41167-0320-4 41167-0320-5 41167-0320-6 41167-0320-7

Sanofi-Aventis U.S. LLC

CGMP Deviations: Presence of NDMA impurity detected in product.

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 68151-2584-0.

Sanofi-Aventis U.S. LLC

CGMP Deviations: Presence of NDMA impurity detected in product.

Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 67751-151-01.

Sanofi-Aventis U.S. LLC

CGMP Deviations: Presence of NDMA impurity detected in product.

Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 0597-0122-01 0597-0122-08 0597-0122-13 0597-0122-37 0597-0122-40 0597-0122-54 0597-0122-61 0597-0122-81 0597-0122-96

Sanofi-Aventis U.S. LLC

CGMP Deviations: Presence of NDMA impurity detected in product.

Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 05269-220-25.

Sanofi-Aventis U.S. LLC

CGMP Deviations: Presence of NDMA impurity detected in product.

October 21, 2019 · DrugView details →

Class IIITerminated

PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose Container, 5 x 10 mL pre-filled syringes, Nephron 503B Outsourcing Facility 4500 12th St. Ext West Columbia, SC 29172, NDC 69374-919-10.

Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center

Incorrect labeling: Incorrect or missing lot and/or exp date

Miracle Facelift Masque, All Natural, The Miracle in a Bottle, 2 fl. oz./60 mL bottle, Kim Kaufman Productions Nashville, TN.

Basic Reset Inc.

Marketed without an Approved NDA/ANDA

Basic Reset CBD Reset 750 True Full Spectrum Cinnamon, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075

Basic Reset Inc.

Marketed without an Approved NDA/ANDA

Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL. OZ., 118.3 mL bottle, Distributed by: Basic Reset Hendersonville, TN 37075

Basic Reset Inc.

Marketed without an Approved NDA/ANDA

Basic Reset Earth Wash Cleaner and Personal Care, Eco Friendly, Non Toxic, 2 fl.oz. bottle, Distributed by: Basic Reset Hendersonville, TN 37075.

Basic Reset Inc.

Marketed without an Approved NDA/ANDA

Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93

Mylan Pharmaceuticals Inc.

Failed Dissolution Specification: Low out of specification dissolution results.

Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075

Basic Reset Inc.

Marketed without an Approved NDA/ANDA

Basic Reset CBD Reset 750 True Full Spectrum Wintergreen, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075

Basic Reset Inc.

Marketed without an Approved NDA/ANDA

BIOGENYX True Full Spectrum CBD Oil Natural Flavor, 1 fl. oz. (30 mL) bottle, 2400 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075

Basic Reset Inc.

Marketed without an Approved NDA/ANDA

Nuovi Firming Masque, Renew and Reset, 2 fl. oz. 59 mL bottle, Made in USA exclusively for Basic Reset 260 W. Main St., Ste 103 Hendersonville, TN 37075

Basic Reset Inc.

Marketed without an Approved NDA/ANDA

BIOGENYX True Full Spectrum CBD Oil Wintergreen, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075

Basic Reset Inc.

Marketed without an Approved NDA/ANDA

BIOGENYX True Full Spectrum CBD Oil Cinnamon, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075

Basic Reset Inc.

Marketed without an Approved NDA/ANDA