Class I · High risk Completed
Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57 G), Dist. by Insight Pharmaceuticals Corp…
Reason Chemical Contamination: presence of benzene
FDA Drug Recalls
32 recalls, newest first
Class II · Moderate risk Completed
ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135…
Reason STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source…
Class I · High risk Completed
TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET WT 4.5 oz (128 g) cans, Distributed by: Insight…
Reason Chemical Contamination; presence of benzene.
Class II · Moderate risk Completed
ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC…
Reason Lack of assurance of sterility.
Class III · Low risk Completed
Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: Siegried Barbera, S.L., Barbera del Valles…
Reason Failed Dissolution Specifications
Class I · High risk Completed
Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc…
Reason Defective Container: powder may leak out of the pouch
Class II · Moderate risk Completed
Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation…
Reason Failed pH Specifications
Class II · Moderate risk Completed
Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd…
Reason Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class II · Moderate risk Completed
Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd…
Reason Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class II · Moderate risk Completed
Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi…
Reason Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class I · High risk Completed
BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey…
Reason Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial…
Class II · Moderate risk Completed
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml)…
Reason Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond…
Class III · Low risk Completed
Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC…
Reason Cross contamination with other products
Class III · Low risk Completed
Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann…
Reason Failed dissolution specifications: below specification results at stability 12-month
Class III · Low risk Completed
Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare…
Reason Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Class II · Moderate risk Completed
Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use Vials, Rx Only…
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk Completed
AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC…
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk Completed
activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% in diluted Activator Solution, Net 1 FL. OZ…
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk Completed
Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide 6.6%), labeled as a) NET WT 1 OZ (28 g) tubes…
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk Completed
ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged in a 7 FLUID OZ (207 ml) bottles, UPC 7 18864 20102…
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk Completed
YAGER'S LINIMENT (Camphor and Turpentine Oil) 3.1% and 8.12% respectively, packaged in a) 4 FL OZ (118 mL) bottles, UPC 0 11169…
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk Completed
Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottles, UPC 0 11169 20011 8 and b) 1.85 FLUID OZ…
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk Completed
Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton, Rx Only, For Oral Use Only - Not For…
Reason CGMP deviation: product released prior to supplier approval.
Class II · Moderate risk Completed
Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walgreen Co…
Reason Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of…
Class II · Moderate risk Completed
ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded by: Empower…
Reason Mislabeling: preservative free product labeled as preserved.