April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repa
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/m
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mc
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 75
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharma
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceutical
Hazard: Lack of Assurance of Sterility
March 27, 2024DrugsFDA
Super Chill Products recalls Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th
Hazard: Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
March 27, 2024DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley He
Hazard: The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
March 27, 2024DrugsFDA
Eugia US LLC recalls Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Prin
Hazard: Failed Impurities/Degradation Specifications: Out of specification for organic impurities
March 27, 2024DrugsFDA
Eugia US LLC recalls Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharm
Hazard: Failed Impurities/Degradation Specifications: Out of specification for organic impurities
March 27, 2024DrugsFDA
Novitium Pharma LLC recalls Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Driv
Hazard: Cross Contamination with Other Products:(mycophenolate mofetil).
March 20, 2024DrugsFDA
Micro Labs Limited recalls Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA, M
Hazard: Failed Stability Specifications: Out of specification for blend uniformity.
March 20, 2024DrugsFDA
Global Corporation recalls Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in 13g sachets, 25 sachets
Hazard: Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
March 20, 2024DrugsFDA
Global Corporation recalls Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL bottles, Made in Do
Hazard: Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
March 20, 2024DrugsFDA
Eugia US LLC recalls Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE
Hazard: Failed Stability Specification: Water determination was found not complying with specification.
March 20, 2024DrugsFDA
Optikem International, Inc. recalls hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Plat
Hazard: Lack of Assurance of Sterility
March 20, 2024DrugsFDA
Optikem International, Inc. recalls TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc,
Hazard: Lack of Assurance of Sterility
March 20, 2024DrugsFDA
Optikem International, Inc. recalls TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc,
Hazard: Lack of Assurance of Sterility
March 20, 2024DrugsFDA
Optikem International, Inc. recalls TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc
Hazard: Lack of Assurance of Sterility
March 20, 2024DrugsFDA
Optikem International, Inc. recalls TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucch
Hazard: Lack of Assurance of Sterility
March 20, 2024DrugsFDA
Optikem International, Inc. recalls TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Deluc
Hazard: Lack of Assurance of Sterility
March 20, 2024DrugsFDA
Optikem International, Inc. recalls TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi
Hazard: Lack of Assurance of Sterility
March 20, 2024DrugsFDA
Optikem International, Inc. recalls TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Del
Hazard: Lack of Assurance of Sterility
March 20, 2024DrugsFDA
Optikem International, Inc. recalls TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane,
Hazard: Lack of Assurance of Sterility
March 20, 2024DrugsFDA
Optikem International, Inc. recalls TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL), Manufactured for TRP Company, In
Hazard: Lack of Assurance of Sterility
March 20, 2024DrugsFDA
Thea Pharma, Inc. recalls Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 024
Hazard: Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
March 20, 2024DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceut
Hazard: cGMP Deviations: Products were stored outside the drug label specifications.