DrugNov 13, 2019
First Royal Care Co. LLC, dba Red Mountain S-MIC/B12(C)/CARNITINE 25/50/50/1/50MG/ML MDV INJ recall — FDA D-0274-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedFirst Royal Care Co. LLC, dba Red Mountain Compounding…
November 2019 recalls — page 22
These records include useful source details for the selected month.
DrugNov 13, 2019
First Royal Care Co. LLC, dba Red Mountain S-TRIMIX various strengths to include:a) S-TRIMIX recall — FDA D-0297-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedFirst Royal Care Co. LLC, dba Red Mountain Compounding…
DrugNov 13, 2019
Basic Reset BIOGENYX True Full Spectrum CBD Oil Wintergreen, 1 fl. oz. (30 mL) bottle, 750 recall — FDA D-0195-2020
Marketed without an Approved NDA/ANDA
Class IIFDA: TerminatedBasic Reset Inc.
DrugNov 13, 2019
Basic Reset Nuovi Firming Masque, Renew and Reset, 2 fl. oz. 59 mL bottle, Made in USA recall — FDA D-0190-2020
Marketed without an Approved NDA/ANDA
Class IIFDA: TerminatedBasic Reset Inc.
DrugNov 13, 2019
RANITIDINE HYDROCHLORIDE Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles recall — FDA D-0168-2020
CGMP Deviations: Presence of NDMA impurity detected in product.
Class IIFDA: CompletedDr. Reddy's Laboratories, Inc.
DrugNov 13, 2019
Dr. Reddy's Laboratories Ranitidine Tablets, USP 150 mg, a.) 95 count bottles recall — FDA D-0176-2020
CGMP Deviations: Presence of NDMA impurity detected in product.
Class IIFDA: CompletedDr. Reddy's Laboratories, Inc.
DrugNov 13, 2019
Basic Reset BIOGENYX True Full Spectrum CBD Oil Natural Flavor, 1 fl. oz. (30 mL) bottle recall — FDA D-0196-2020
Marketed without an Approved NDA/ANDA
Class IIFDA: TerminatedBasic Reset Inc.
DrugNov 13, 2019
Dr. Reddy's Laboratories Ranitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray recall — FDA D-0169-2020
CGMP Deviations: Presence of NDMA impurity detected in product.
Class IIFDA: CompletedDr. Reddy's Laboratories, Inc.
DrugNov 13, 2019
Basic Reset CBD Reset 750 True Full Spectrum Wintergreen, 750 mg CBD, 1 fl. oz. (30 mL) recall — FDA D-0191-2020
Marketed without an Approved NDA/ANDA
Class IIFDA: TerminatedBasic Reset Inc.
DrugNov 13, 2019
Dr. Reddy's Laboratories Ranitidine Tablets, USP 150 mg, a.) 24 count bottles recall — FDA D-0172-2020
CGMP Deviations: Presence of NDMA impurity detected in product.
Class IIFDA: CompletedDr. Reddy's Laboratories, Inc.
DrugNov 13, 2019
Dr. Reddy's Laboratories Ranitidine Tablets, USP 75 mg, a.) 30- count bottles recall — FDA D-0183-2020
CGMP Deviations: Presence of NDMA impurity detected in product.
Class IIFDA: CompletedDr. Reddy's Laboratories, Inc.
DrugNov 13, 2019
Lupin Pharmaceuticals Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle recall — FDA D-0304-2020
Presence of Foreign substance: identified as a dead ant.
Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugNov 13, 2019
Cefdinir for Oral Suspension USP, 125 mg/5mL recall — FDA D-0306-2020
Presence of Foreign substance: identified as a dead ant.
Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugNov 13, 2019
Dr. Reddy's Laboratories Ranitidine Tablets, USP 150 mg, a.) 24 count bottles recall — FDA D-0184-2020
CGMP Deviations: Presence of NDMA impurity detected in product.
Class IIFDA: CompletedDr. Reddy's Laboratories, Inc.
DrugNov 13, 2019
Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle recall — FDA D-0305-2020
Presence of Foreign substance: identified as a dead ant.
Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugNov 13, 2019
Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. oz. (30 mL) recall — FDA D-0193-2020
Marketed without an Approved NDA/ANDA
Class IIFDA: TerminatedBasic Reset Inc.
DrugNov 13, 2019
Basic Reset Earth Wash Cleaner and Personal Care, Eco Friendly, Non Toxic, 2 fl.oz. bottle recall — FDA D-0187-2020
Marketed without an Approved NDA/ANDA
Class IIFDA: TerminatedBasic Reset Inc.
DrugNov 13, 2019
Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL recall — FDA D-0189-2020
Marketed without an Approved NDA/ANDA
Class IIFDA: TerminatedBasic Reset Inc.
DrugNov 13, 2019
Dr. Reddy's Laboratories Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30) recall — FDA D-0175-2020
CGMP Deviations: Presence of NDMA impurity detected in product.
Class IIFDA: CompletedDr. Reddy's Laboratories, Inc.
DrugNov 13, 2019
Sankaijo BOTANICAL LAXATIVE recall — FDA D-0303-2020
Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
Class IIIFDA: TerminatedSato Pharmaceutical Inc.
DrugNov 13, 2019
Basic Reset CBD Reset 750 True Full Spectrum Cinnamon, 750 mg CBD, 1 fl. oz. (30 mL) bottle recall — FDA D-0192-2020
Marketed without an Approved NDA/ANDA
Class IIFDA: TerminatedBasic Reset Inc.
DrugNov 13, 2019
Basic Reset Miracle Facelift Masque, All Natural, The Miracle in a Bottle, 2 fl. oz./60 mL recall — FDA D-0188-2020
Marketed without an Approved NDA/ANDA
Class IIFDA: TerminatedBasic Reset Inc.
DrugNov 13, 2019
Dr. Reddy's Laboratories Ranitidine Tablets, USP 150 mg, a.) 65 count bottles recall — FDA D-0171-2020
CGMP Deviations: Presence of NDMA impurity detected in product.
Class IIFDA: CompletedDr. Reddy's Laboratories, Inc.
DrugNov 13, 2019
Green Lumber Natural Fuel For Men capsule recall — FDA D-0351-2020
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.
Class IFDA: TerminatedGreen Lumber Holdings, LLC
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.