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FDA Drug Recalls

316 recalls, newest first

Class II · Moderate risk Ongoing Mar 22, 2023

Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC…

Reason CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

Direct Rx NDC 72189-121-60 D-0509-2023

Class II · Moderate risk Ongoing Mar 22, 2023

Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only…

Reason CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

Direct Rx NDC 72189-213-30 D-0508-2023

Class II · Moderate risk Ongoing Mar 22, 2023

Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC…

Reason CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

Direct Rx NDC 72189-0240-30 D-0507-2023

Class II · Moderate risk Ongoing Mar 17, 2023

Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA…

Reason Out of specification (OOS) for Spectroscopic Identification test by IR.

Ascend Laboratories, LLC D-0539-2023

Class II · Moderate risk Ongoing Mar 16, 2023

Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC…

Reason CGMP Deviations

Northwind Pharmaceuticals LLC NDC 51655-487-52 D-0554-2023

Class II · Moderate risk Ongoing Mar 16, 2023

Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx…

Reason CGMP Deviations

Northwind Pharmaceuticals LLC NDC 51655-473-87 D-0553-2023

Class II · Moderate risk Ongoing Mar 16, 2023

Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-120-26), Rx…

Reason CGMP Deviations

Northwind Pharmaceuticals LLC NDC 51655-120-52 D-0552-2023

Class II · Moderate risk Ongoing Mar 16, 2023

Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count bottles (NDC 51655-383-26), Rx…

Reason CGMP Deviations

Northwind Pharmaceuticals LLC NDC 51655-383-52 D-0551-2023

Class II · Moderate risk Ongoing Mar 16, 2023

Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC…

Reason CGMP Deviations

Northwind Pharmaceuticals LLC NDC 51655-109-52 D-0550-2023

Class II · Moderate risk Ongoing Mar 16, 2023

BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indianapolis…

Reason CGMP Deviations

Northwind Pharmaceuticals LLC NDC 51655-511-52 D-0549-2023

Class II · Moderate risk Ongoing Mar 16, 2023

Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN…

Reason CGMP Deviations

Northwind Pharmaceuticals LLC NDC 51655-946-52 D-0548-2023

Class III · Low risk Ongoing Mar 16, 2023

Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufactured for…

Reason Labeling; Incorrect NDC number on outer carton of product.

Focus Health Group Inc D-0535-2023

Class II · Moderate risk Ongoing Mar 14, 2023

Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA…

Reason CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

Ascend Laboratories, LLC NDC 67877-475-60 D-0534-2023

Class II · Moderate risk Ongoing Mar 14, 2023

Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA…

Reason CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

Ascend Laboratories, LLC NDC 67877-474-60 D-0533-2023

Class II · Moderate risk Ongoing Mar 14, 2023

Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc…

Reason CGMP Deviations: Discoloration

Hetero USA Inc NDC 31722-713-10 D-0530-2023

Class I · High risk Ongoing Mar 13, 2023

Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc…

Reason Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged…

Camber Pharmaceuticals Inc. NDC 31722-629-21 D-0567-2023

Class II · Moderate risk Ongoing Mar 10, 2023

Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC…

Reason Defective Delivery System: Out of specification for shear.

Noven Pharmaceuticals Inc NDC 68968-5555-3 D-0473-2023

Class II · Moderate risk Ongoing Mar 10, 2023

Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC…

Reason Defective Delivery System: Out of specification for shear.

Noven Pharmaceuticals Inc NDC 68968-5554-3 D-0472-2023

Class II · Moderate risk Ongoing Mar 10, 2023

Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC…

Reason Defective Delivery System: Out of specification for shear.

Noven Pharmaceuticals Inc NDC 68968-5553-3 D-0471-2023

Class II · Moderate risk Ongoing Mar 10, 2023

Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC…

Reason Defective Delivery System: Out of specification for shear.

Noven Pharmaceuticals Inc NDC 68968-5552-3 D-0470-2023

Class III · Low risk Ongoing Mar 8, 2023

MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned subsidiary…

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is…

Pfizer Inc. D-0532-2023

Class I · High risk Ongoing Feb 24, 2023

Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed By: Delsam…

Reason Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.

Global Pharma Healthcare Private Limited D-0488-2023

Class II · Moderate risk Ongoing Feb 23, 2023

NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid Drops, 0.1% Alcohol, 1 FL OZ( 30mL), Mfd…

Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Nutraceutical Corporation D-0440-2023

Class II · Moderate risk Ongoing Feb 23, 2023

NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% Alcohol, 1 FL OZ( 30mL), Mfd. for Nutraceutical Corp…

Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Nutraceutical Corporation D-0439-2023

Class II · Moderate risk Ongoing Feb 23, 2023

NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for Healthway Corp. Comments or Questions…

Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Nutraceutical Corporation D-0438-2023