Class III · Low risk Ongoing
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate…
Reason Failed Tablet/Capsule Specifications
Is Basic recalled?
33 FDA recalls mention Basic. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Basic.
Class III · Low risk Terminated
Avicel DG, MCC/Dibasic Calcium Phosphate, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont…
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class II · Moderate risk Terminated
NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial, Each ML contains…
Reason Product found to be Sub Potent or Exceeded reconstitution time
Class II · Moderate risk Terminated
amazon basic+care, Allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech…
Reason Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk Terminated
basic+care, allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech Republic…
Reason Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk Terminated
basic+care, allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 150 count bottle, Made in the Czech…
Reason Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk Terminated
VILEVEV MB Urinary Antispetic (81.0 mg methenamine, 40.8 mg sodium phosphate monobasic and 10.8 mg methylene blue, 0.12 mg…
Reason cGMP deviations
Class II · Moderate risk Terminated
VILAMIT MB (118 mg methenamine, 36 mg phenyl salicylate, 40.8 mg sodium phosphate monobasic, 10.0 mg methylene blue and 0.12 mg…
Reason cGMP deviations
Class I · High risk Terminated
BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3, Made in…
Reason Chemical Contamination: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were…
Class II · Moderate risk Terminated
BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), packaged as a) 9.5 FL OZ (280 mL) bottle, UPC 8 40038…
Reason CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled…
Class II · Moderate risk Terminated
Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceutical Chemical, packaged in a) 500G glass bottles…
Reason Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
Class II · Moderate risk Terminated
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. [Brand, NDC] NDC Basic Care…
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care…
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-01…
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Basic Care…
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 tablets per bottle. [NDC: Brand] NDC Basic Care: 0113-7876-27…
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Basic Reset CBD Reset 2400, True Full Spectrum Natural (unflavored), 2400 mg CBD, 1 fl. oz. (29 mL) bottle, Distributed by: Basic…
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset…
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
Basic Reset CBD Reset 750 True Full Spectrum Cinnamon, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset…
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
Basic Reset CBD Reset 750 True Full Spectrum Wintergreen, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset…
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
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…
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL. OZ., 118.3 mL bottle, Distributed by: Basic Reset Hendersonville, TN 37075
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
Basic Reset Earth Wash Cleaner and Personal Care, Eco Friendly, Non Toxic, 2 fl.oz. bottle, Distributed by: Basic Reset…
Reason Marketed without an Approved NDA/ANDA
Class I · High risk Terminated
Senna Laxative (sennosides) tablets, 8.6 mg, 100-count bottles, Manufactured for: Basic Drugs, Inc., Vandalia, Ohio 45377, UPC…
Reason Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative contained only tablets of Naproxen Sodium 220 mg.
Class II · Moderate risk Terminated
Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate…
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
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