November 2, 2022DrugsFDA
Golden State Medical Supply Inc. recalls Atenolol Tablets, USP, 25 mg, 1000-count bottle, Rx only, Manufactured by: ALPHAPHARM PTY LTD, Marketed by: GSMS, Incorp
Hazard: Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
November 2, 2022DrugsFDA
VistaPharm, Inc. recalls Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: Vi
Hazard: cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
November 2, 2022DrugsFDA
Ultra Chem Labs Corp recalls Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Green Tea and Aloe, Family Safe
Hazard: Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
November 2, 2022DrugsFDA
Ultra Chem Labs Corp recalls Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, Family Safe, No Gels
Hazard: Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
October 26, 2022DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs,
Hazard: Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
October 26, 2022DrugsFDA
LNK International, Inc. recalls NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COUGH SUPPRE
Hazard: Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
October 26, 2022DrugsFDA
AuroMedics Pharma LLC recalls Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC
Hazard: Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
October 26, 2022DrugsFDA
Golden State Medical Supply Inc. recalls Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by
Hazard: Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
October 26, 2022DrugsFDA
Golden State Medical Supply Inc. recalls Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle (NDC 51407-323-30), b) 60-count bottle (NDC 51407-323-60)
Hazard: Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
October 26, 2022DrugsFDA
Ingenus Pharmaceuticals Llc recalls Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando,
Hazard: Out of specification for related substances (impurities).
October 19, 2022DrugsFDA
Justified Laboratories recalls Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011
Hazard: Marketed Without An Approved NDA/ANDA; Unapproved new drug
October 19, 2022DrugsFDA
Justified Laboratories recalls Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011
Hazard: Marketed Without An Approved NDA/ANDA; Unapproved new drug
October 12, 2022DrugsFDA
AuroMedics Pharma LLC recalls Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics
Hazard: Presence of Particulate Matter: Piece of metal found in a vial
October 12, 2022DrugsFDA
CIPLA recalls Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dos
Hazard: Lack of Assurance of Sterility: environmental monitoring failure.
October 12, 2022DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Re
Hazard: Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
October 12, 2022DrugsFDA
Woodbine Products Co Inc recalls Antibacterial Foaming Wash with Hydria Moisturizing Formula, Cucumber-Melon Scent, 1250 mL (42 fl oz.), Manufactured for
Hazard: Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label.
October 12, 2022DrugsFDA
Pfizer Inc. recalls Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc. L
Hazard: Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
October 12, 2022DrugsFDA
Salon Technologies International Inc recalls Antica Farmacista Hand Sanitizer Ocean Citron (ethyl alcohol, denatured 65%) packaged in 473 mL/16 fl. oz. bottles, Dis
Hazard: Chemical Contamination: product found to contain benzene
October 12, 2022DrugsFDA
Salon Technologies International Inc recalls Sanitizing Hand Spray 80% (alcohol 80% v/v) Packaged in 2 FL OZ (60 mL) bottles, Salon Technologies International 8810 C
Hazard: GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
October 5, 2022DrugsFDA
ALMIRALL, LLC recalls Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 161
Hazard: Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
October 5, 2022DrugsFDA
Akorn, Inc. recalls Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748-018-60), c) 100-cou
Hazard: Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
October 5, 2022DrugsFDA
Akorn, Inc. recalls Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031
Hazard: Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
October 5, 2022DrugsFDA
Leading Pharma, LLC recalls ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Phar
Hazard: Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
October 5, 2022DrugsFDA
CIPLA recalls Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules pe
Hazard: Lack of Assurance of Sterility
October 5, 2022DrugsFDA
QuVa Pharma, Inc. recalls oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Comp
Hazard: Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
October 5, 2022DrugsFDA
Novartis Pharmaceuticals Corporation recalls Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton,
Hazard: CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
October 5, 2022DrugsFDA
Viatris Inc recalls Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 x 2 g vials per carton NDC 67457-352-10, Rx
Hazard: Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
October 5, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Labora
Hazard: Superpotent Drug: Out of specification for assay at the 12-month timepoint.
October 5, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laborat
Hazard: Superpotent Drug: Out of specification for assay at the 12-month timepoint.
September 28, 2022DrugsFDA
UNICHEM PHARMACEUTICALS USA INC recalls Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pile
Hazard: Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,