June 5, 2024DrugsFDA
ARG Laboratories, Inc. recalls Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad Spectrum Sunscreen with UVA/UVB
Hazard: Out of Specification for active ingredient
June 5, 2024DrugsFDA
ARG Laboratories, Inc. recalls NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%) Enriched with Capsaicin, Aloe Vera, Willow Bark & M
Hazard: Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
June 5, 2024DrugsFDA
ARG Laboratories, Inc. recalls Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor,
Hazard: Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
June 5, 2024DrugsFDA
Imprimis NJOF, LLC recalls Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intraocular Injection, Impr
Hazard: Lack of Assurance of Sterility
June 5, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceutic
Hazard: Defective container: lack of seal integrity.
June 5, 2024DrugsFDA
Rubicon Research Private Limited recalls Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manu
Hazard: Presence of Foreign Substance: metal in tablet
June 5, 2024DrugsFDA
Imprimis NJOF, LLC recalls Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC
Hazard: Lack of Assurance of Sterility
June 5, 2024DrugsFDA
Imprimis NJOF, LLC recalls Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, L
Hazard: Lack of Assurance of Sterility
June 5, 2024DrugsFDA
Imprimis NJOF, LLC recalls Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Int
Hazard: Lack of Assurance of Sterility
June 5, 2024DrugsFDA
Imprimis NJOF, LLC recalls Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx on
Hazard: Lack of Assurance of Sterility
June 5, 2024DrugsFDA
Imprimis NJOF, LLC recalls Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imp
Hazard: Lack of Assurance of Sterility
June 5, 2024DrugsFDA
Revive Rx LLC dba Revive Rx Pharmacy recalls Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pha
Hazard: Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
June 5, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laborat
Hazard: Lack of Assurance of Sterility: Leaking vials
June 5, 2024DrugsFDA
Genentech, Inc. recalls Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Hazard: Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
May 29, 2024DrugsFDA
Hikma Injectables USA Inc recalls Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables US
Hazard: Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
May 29, 2024DrugsFDA
American Regent, Inc. recalls Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous I
Hazard: Subpotent product in addition to having out-of-specification results for impurities.
May 29, 2024DrugsFDA
SOMERSET THERAPEUTICS LLC recalls Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-D
Hazard: Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
May 29, 2024DrugsFDA
Preferred Pharmaceuticals, Inc. recalls Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
May 29, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08
Hazard: Failed Impurities/Degradation Specifications
May 29, 2024DrugsFDA
American Regent, Inc. recalls niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenou
Hazard: Lack of Assurance of Sterility.
May 29, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceuti
Hazard: Failed Release Testing: Out of specification for particulate matter test.
May 22, 2024DrugsFDA
Pharma Nobis LLC recalls Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free Grape, 10 fl. oz bottle, Distributed by: Mei
Hazard: Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
May 22, 2024DrugsFDA
Pharma Nobis LLC recalls CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Flavor, 10 fl. oz bottle, Distributed by: CVS
Hazard: Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
May 22, 2024DrugsFDA
Sagent Pharmaceuticals recalls MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx on
Hazard: Presence of Particulate Matter: Potential for black particulates in the drug product.
May 22, 2024DrugsFDA
MACLEODS PHARMA USA, INC recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Mac
Hazard: Presence of foreign substance: plastic-like substance.
May 22, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin
Hazard: Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
May 22, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin
Hazard: Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
May 22, 2024DrugsFDA
Dercher Enterprises, Inc., DBA Gordon Laboratories recalls Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 1908
Hazard: cGMP Deviations
May 22, 2024DrugsFDA
Stop Clopez Corp recalls Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by VSD Productions Inc., Las Vegas
Hazard: Marketed Without An Approved NDA/ANDA
May 15, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury
Hazard: Out of specification for assay