Class II · Moderate risk Ongoing
Glutathione Magnesium for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL…
Reason Lack of Assurance of Sterility
FDA Drug Recalls
723 recalls, newest first
Class II · Moderate risk Ongoing
GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
GAC for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Calcium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Biotin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
B-Complex for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Bacteriostatic Water for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
B6 (Pyridoxine HCl) for Injections, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
B5 Dexpanthenol for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
B12 Hydroxocobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Ascorbic Acid (Vitamin C) for Injection, Preserved, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Ascorbic Acid (Vitamin C) for Injection, Preservative Free, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Alpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217…
Reason CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot…
Class II · Moderate risk Ongoing
Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, Distributed by: Pfizer Inc., New York, NY 10017…
Reason Subpotent drug
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe…
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II · Moderate risk Ongoing
Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v…
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class III · Low risk Ongoing
Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore…
Reason Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the…
Class II · Moderate risk Ongoing
BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, Antiseptic, 100 towelettes per carton…
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Ongoing
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC#…
Reason Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Class II · Moderate risk Ongoing
Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per carton, AUM Pharmaceuticals, 320 Oser Ave., Hauppauge…
Reason cGMP Deviations
Class II · Moderate risk Ongoing
Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only…
Reason Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the…
Class II · Moderate risk Ongoing
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd…
Reason Failed Dissolution Specifications: low dissolution results