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FDA Drug Recalls

17,898 recalls, newest first

Class II · Moderate risk Ongoing Feb 23, 2023

NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, 0.8 fl oz( 24mL), Mfd. Nutraceutical Corp…

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

Nutraceutical Corporation D-0437-2023

Class II · Moderate risk Terminated Feb 23, 2023

Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech…

Reason Packaging defect: observed packaging defect, blister packaging inadequately sealed.

The Harvard Drug Group NDC 0904-7257-61 D-0432-2023

Class II · Moderate risk Terminated Feb 23, 2023

Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia, SC 29172…

Reason CGMP Deviations: Potential product carryover.

Nephron Sc Inc NDC 0487-6105-01 D-0364-2023

Class II · Moderate risk Terminated Feb 22, 2023

Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL…

Reason CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Teva Pharmaceuticals USA Inc NDC 00591-2720-60 D-0441-2023

Class II · Moderate risk Terminated Feb 22, 2023

Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle…

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC NDC 69374-321-25 D-0362-2023

Class II · Moderate risk Terminated Feb 22, 2023

Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per…

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC NDC 69374-301-10 D-0361-2023

Class II · Moderate risk Terminated Feb 22, 2023

Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per…

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC NDC 69374-305-10 D-0360-2023

Class II · Moderate risk Terminated Feb 22, 2023

Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose…

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC NDC 69374-302-10 D-0359-2023

Class II · Moderate risk Terminated Feb 22, 2023

Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle…

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC NDC 69374-315-25 D-0358-2023

Class II · Moderate risk Terminated Feb 22, 2023

Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle…

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC NDC 69374-319-25 D-0357-2023

Class II · Moderate risk Terminated Feb 22, 2023

Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container…

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC NDC 69374-316-25 D-0356-2023

Class II · Moderate risk Terminated Feb 22, 2023

Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1…

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC NDC 69374-997-15 D-0355-2023

Class III · Low risk Ongoing Feb 21, 2023

Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only…

Reason Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the…

Padagis US LLC D-0464-2023

Class II · Moderate risk Terminated Feb 21, 2023

Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796…

Reason CGMP DEVIATIONS

Denver Solutions, LLC DBA Leiters Health NDC 71449-148-94 D-0445-2023

Class II · Moderate risk Terminated Feb 21, 2023

Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd…

Reason CGMP DEVIATIONS

Denver Solutions, LLC DBA Leiters Health NDC 71449-150-82 D-0444-2023

Class II · Moderate risk Terminated Feb 21, 2023

Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC…

Reason CGMP DEVIATIONS

Denver Solutions, LLC DBA Leiters Health NDC 71449-001-15 D-0443-2023

Class II · Moderate risk Terminated Feb 21, 2023

Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC…

Reason CGMP DEVIATIONS

Denver Solutions, LLC DBA Leiters Health NDC 71449-001-11 D-0442-2023

Class III · Low risk Terminated Feb 17, 2023

DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ 07004, NDC 71399-2829-1

Reason Labeling: Incorrect or Missing Lot and/or Exp Date

Akron Pharma, Inc. NDC 71399-2829-1 D-0454-2023

Class III · Low risk Terminated Feb 17, 2023

Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY…

Reason Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.

Sciegen Pharmaceuticals Inc D-0354-2023

Class II · Moderate risk Terminated Feb 15, 2023

Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL…

Reason cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

Azurity Pharmaceuticals, Inc. NDC 52536-625-10 D-0489-2023

Class III · Low risk Terminated Feb 15, 2023

Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured…

Reason Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the…

AVEVA Drug Delivery Systems, Inc. NDC 60505-7079-05 D-0466-2023

Class III · Low risk Terminated Feb 15, 2023

Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured…

Reason Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the…

AVEVA Drug Delivery Systems, Inc. NDC 60505-7077-05 D-0465-2023

Class II · Moderate risk Terminated Feb 15, 2023

Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC#…

Reason Failed Impurities/Degradation Specifications

Rising Pharmaceuticals NDC 57237-119-01 D-0348-2023

Class II · Moderate risk Ongoing Feb 14, 2023

Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Manufactured by: Pharmedica USA, Phoenix, AZ, UPC 7…

Reason CGMP Deviations

Pharmedica USA, LLC D-0457-2023

Class I · High risk Ongoing Feb 14, 2023

Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 91382 9; and b) 30 ml, 1.014 fl oz bottle, UPC 7…

Reason Non-Sterility

Pharmedica USA, LLC D-0456-2023