February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Op
Hazard: Lack of Assurance of Sterility.
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL p
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL single use syring
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 mL (22.5 mg/mL), 0.5mL single us
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe, Edge Pharma, L
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration and
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pha
Hazard: Lack of Assurance of Sterility
February 2, 2022DrugsFDA
Ascend Laboratories, LLC recalls Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Labor
Hazard: Failed Dissolution Specifications.
February 2, 2022DrugsFDA
VIONA PHARMACEUTICALS INC recalls Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
Hazard: CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
January 26, 2022DrugsFDA
Mylan Pharmaceuticals Inc recalls Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 m
Hazard: Labeling: Missing Label: label missing from some Semglee prefilled pens.
January 26, 2022DrugsFDA
Medique Products recalls Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per
Hazard: CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
January 26, 2022DrugsFDA
Medique Products recalls Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablets, packaged in 2-count Tablets pe
Hazard: CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
January 26, 2022DrugsFDA
Medique Products recalls Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg, pack
Hazard: CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
January 26, 2022DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, packaged in 36-count blister pack packed into c
Hazard: Subpotent drug
January 26, 2022DrugsFDA
Mayne Pharma Inc recalls Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville,
Hazard: CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
January 26, 2022DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongest
Hazard: Failed Dissolution Specifications
January 26, 2022DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 E
Hazard: Failed Dissolution Specifications
January 26, 2022DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & Conges
Hazard: Failed Dissolution Specifications
January 26, 2022DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrine HCl 120mg/Nasal Decongestant Extended-Rel
Hazard: Failed Dissolution Specifications
January 26, 2022DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets per box, UPC
Hazard: Failed Dissolution Specifications
January 26, 2022DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended-Rel
Hazard: Failed Dissolution Specifications
January 26, 2022DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg, Extended Release Tablets USP
Hazard: Failed Dissolution Specifications
January 26, 2022DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Table
Hazard: Failed Dissolution Specifications
January 26, 2022DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended Release Tablets
Hazard: Failed Dissolution Specifications
January 26, 2022DrugsFDA
Lohxa, LLC recalls SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC 50
Hazard: Microbial Contamination of Non-Sterile Product
January 26, 2022DrugsFDA
VistaPharm, Inc. recalls Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 666
Hazard: Failed Stability Specifications
January 26, 2022DrugsFDA
Ingenus Pharmaceuticals Llc recalls Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx o
Hazard: CGMP Deviations
January 26, 2022DrugsFDA
Teva Pharmaceuticals USA recalls Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropper
Hazard: Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not dispensing.
January 19, 2022DrugsFDA
Akorn, Inc. recalls Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warni
Hazard: Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
January 19, 2022DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay,
Hazard: Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria