August 30, 2023DrugsFDA
Ecometics, Inc. recalls 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) tu
Hazard: CGMP Deviations: Products not manufactured under current good manufacturing practices.
August 30, 2023DrugsFDA
Ecometics, Inc. recalls ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged in a 7 FLUID OZ (207 ml) bottles, UPC 7 188
Hazard: CGMP Deviations: Products not manufactured under current good manufacturing practices.
August 30, 2023DrugsFDA
Ecometics, Inc. recalls YAGER'S LINIMENT (Camphor and Turpentine Oil) 3.1% and 8.12% respectively, packaged in a) 4 FL OZ (118 mL) bottles, UPC
Hazard: CGMP Deviations: Products not manufactured under current good manufacturing practices.
August 30, 2023DrugsFDA
Ecometics, Inc. recalls 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
Hazard: CGMP Deviations: Products not manufactured under current good manufacturing practices.
August 30, 2023DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured
Hazard: Subpotent: Out of Specification for Assay Test at the 3-month time point.
August 30, 2023DrugsFDA
Imprimis NJOF, LLC recalls Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West,
Hazard: Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
August 30, 2023DrugsFDA
Parker Laboratories, Inc. recalls Helix CBD Clinical Cream (Menthol 7.4%), packaged in a)3 gm pouches (NDC30775-054-01), b)2 fl. oz. tubes (NDC 30775-054-
Hazard: CGMP Deviations
August 30, 2023DrugsFDA
Parker Laboratories, Inc. recalls Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-053-01), b) 2 fl. oz. tubes (NDC 30775-053-0
Hazard: CGMP Deviations
August 30, 2023DrugsFDA
Parker Laboratories, Inc. recalls Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%), packaged in a) 3 fl. oz. roll-on (
Hazard: CGMP Deviations
August 30, 2023DrugsFDA
Parker Laboratories, Inc. recalls Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01), b) 3 fl. oz. roll-on (NDC 30775
Hazard: CGMP Deviations
August 30, 2023DrugsFDA
Parker Laboratories, Inc. recalls Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2 fl oz/60 mL Pump bottles (NDC 30775-040-02
Hazard: CGMP Deviations
August 30, 2023DrugsFDA
Aurobindo Pharma USA Inc. recalls Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279
Hazard: cGMP deviations: Batch was released prior to approval.
August 30, 2023DrugsFDA
Aurobindo Pharma USA Inc. recalls Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279
Hazard: cGMP deviations: Batch was released prior to approval.
August 23, 2023DrugsFDA
ALEMBIC PHARMACEUTICALS, INC. recalls Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ
Hazard: Failed Impurities/Degradation Specifications
August 23, 2023DrugsFDA
Advanced Accelerator Applications USA, Inc. recalls PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacture
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
August 23, 2023DrugsFDA
Colgate Palmolive Company recalls hello wild strawberry fluoride toothpaste, sodium fluoride 0.24% (0.15% w/v fluoride ion), NET WT 4.2 OZ (119 g), Distri
Hazard: Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons labeled as hello wild strawberry fluoride toothpaste were incorrectly filled in tubes labeled as hello fresh watermelon fluoride free toothpaste.
August 16, 2023DrugsFDA
B. Braun Medical Inc. recalls 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, ND
Hazard: Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
August 16, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Su
Hazard: Out of Specification result observed in content uniformity testing
August 9, 2023DrugsFDA
Lupin Pharmaceuticals Inc. recalls Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium
Hazard: Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
August 9, 2023DrugsFDA
Central Admixture Pharmacy Services Inc recalls morphine in 0.9% Sodium Chloride, 50 mg/50 mL (1mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc
Hazard: Lack of assurance of sterility: Lack of validation data for sanitization cycles
August 9, 2023DrugsFDA
Central Admixture Pharmacy Services Inc recalls fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services,
Hazard: Lack of assurance of sterility: Lack of validation data for sanitization cycles
August 9, 2023DrugsFDA
Central Admixture Pharmacy Services Inc recalls PHENYLephrine in 0.9 sodium chloride, 400 mcg /10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Roa
Hazard: Lack of assurance of sterility: Lack of validation data for sanitization cycles
August 9, 2023DrugsFDA
Central Admixture Pharmacy Services Inc recalls PHENYLephrine in 0.9 sodium chloride, 800 mcg /10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Roa
Hazard: Lack of assurance of sterility: Lack of validation data for sanitization cycles
August 9, 2023DrugsFDA
Central Admixture Pharmacy Services Inc recalls rocuronium, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Roa
Hazard: Lack of assurance of sterility: Lack of validation data for sanitization cycles
August 9, 2023DrugsFDA
Central Admixture Pharmacy Services Inc recalls midazolam in dextrose 5%, 50 mg /50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 79
Hazard: Lack of assurance of sterility: Lack of validation data for sanitization cycles
August 9, 2023DrugsFDA
Central Admixture Pharmacy Services Inc recalls lidocaine 2%, 100 mg /5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92
Hazard: Lack of assurance of sterility: Lack of validation data for sanitization cycles
August 9, 2023DrugsFDA
Central Admixture Pharmacy Services Inc recalls ePHEDrine in 0.9% sodium chloride, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road,
Hazard: Lack of assurance of sterility: Lack of validation data for sanitization cycles
August 9, 2023DrugsFDA
Central Admixture Pharmacy Services Inc recalls fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250
Hazard: Lack of assurance of sterility: Lack of validation data for sanitization cycles
August 9, 2023DrugsFDA
Central Admixture Pharmacy Services Inc recalls ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C,
Hazard: Lack of assurance of sterility: Lack of validation data for sanitization cycles
August 9, 2023DrugsFDA
Central Admixture Pharmacy Services Inc recalls fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 100 mL, Total FentaNYL 200 mcg/100 m
Hazard: Lack of assurance of sterility: Lack of validation data for sanitization cycles