October 27, 2021DrugsFDA
Beiersdorf Inc recalls Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc
Hazard: Chemical contamination; presence of benzene
October 27, 2021DrugsFDA
Beiersdorf Inc recalls Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc
Hazard: Chemical contamination; presence of benzene
October 27, 2021DrugsFDA
Beiersdorf Inc recalls Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wi
Hazard: Chemical contamination; presence of benzene
October 20, 2021DrugsFDA
Eli Lilly & Company recalls Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe. R
Hazard: SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
October 20, 2021DrugsFDA
SSM Health Care St. Louis DBA SSM St. Clare Health Center recalls Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx Only, SSM Health Care Corporation, 1015 Bowl
Hazard: Lack of Assurance of Sterility
October 20, 2021DrugsFDA
Strides Pharma Inc. recalls Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun
Hazard: Failed Dissolution Specifications
October 13, 2021DrugsFDA
RISING PHARMACEUTICALS recalls Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Bruns
Hazard: Labeling: Incorrect Instructions
October 13, 2021DrugsFDA
Akorn, Inc. recalls Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured
Hazard: Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
October 13, 2021DrugsFDA
Azurity Pharmaceuticals, Inc. recalls Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing 7.
Hazard: Product Mix-up: Incorrect diluent component included in the kit.
October 13, 2021DrugsFDA
AMIVAS (US), LLC recalls Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01)
Hazard: Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
October 13, 2021DrugsFDA
Alpha-Tek LLC recalls ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC
Hazard: Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
October 6, 2021DrugsFDA
New Vitalis Pharmacy LLC dba New Vitalis Pharmacy recalls Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial, Rx only, New Vitalis Pharmacy 4139 Cadill
Hazard: Lack of Assurance of Sterility
October 6, 2021DrugsFDA
SigmaPharm Laboratories LLC recalls Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton
Hazard: Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
October 6, 2021DrugsFDA
IntegraDose Compounding Services LLC recalls ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC,
Hazard: Lack of sterility assurance.
October 6, 2021DrugsFDA
IntegraDose Compounding Services LLC recalls ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 K
Hazard: Lack of sterility assurance.
October 6, 2021DrugsFDA
Washington Homeopathic Products, Inc. recalls Aconitum Napellus 12X Fear* 87% Alcohol HPUS: packaged in 30 mL containers; WHP Homeopathic Medicine, Washington Homeopa
Hazard: Out-of-specification test results obtained for identification testing based on HPTLC analysis.
October 6, 2021DrugsFDA
Washington Homeopathic Products, Inc. recalls Aconitum nap Fear* 20% Alcohol HPUS: 6X, packaged in 50mL & 8 oz containers Aconitum nap Fear* 20% Alcohol HPUS: 7X, 12X
Hazard: Out-of-specification test results obtained for identification testing based on HPTLC analysis.
October 6, 2021DrugsFDA
Washington Homeopathic Products, Inc. recalls Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 8X, 9X, 12X,30X, packaged in 1 oz containers, Aconitum Napellus Fear
Hazard: Out-of-specification test results obtained for identification testing based on HPTLC analysis.
October 6, 2021DrugsFDA
Washington Homeopathic Products, Inc. recalls Aconitum nap Fear* Sucrose/Lactose Pills HPUS: 4X, 5X, 6X,15X, packaged in 1 oz containers, Aconitum nap Fear* Sucrose/L
Hazard: Out-of-specification test results obtained for identification testing based on HPTLC analysis.
October 6, 2021DrugsFDA
Washington Homeopathic Products, Inc. recalls Aconitum Napellus Fear* 20% Alcohol HPUS: 5X, 6X, 26X, 30X, packaged in 15mL containers, Aconitum Napellus Fear* 20% Alc
Hazard: Out-of-specification test results obtained for identification testing based on HPTLC analysis.
October 6, 2021DrugsFDA
Washington Homeopathic Products, Inc. recalls Strophanthus hisp 30X, Hives*, Sucrose/Lactose Pills , Packaged in (a) 2 dr, UPC 7 40640 47533 1; (b) 4 dr UPC 7 40640 4
Hazard: Out-of-specification test results obtained for identification testing based on HPTLC analysis.
October 6, 2021DrugsFDA
Washington Homeopathic Products, Inc. recalls Strophanthus hisp 30X, Hives*, 20% Alcohol, Packaged in (a) 15 mL, UPC 7 40640 47553 9; (b) 30mL UPC 7 40640 47557 7; (c
Hazard: Out-of-specification test results obtained for identification testing based on HPTLC analysis.
October 6, 2021DrugsFDA
Washington Homeopathic Products, Inc. recalls ZTE 1015 Formula, Contents 1000 ml, For Manufacturing Use only, REMEDY: Argentum Nitricum 10X, Rhus Toxicodendron 10X, A
Hazard: Out-of-specification test results obtained for identification testing based on HPTLC analysis.
October 6, 2021DrugsFDA
Washington Homeopathic Products, Inc. recalls ZTE 1013 Formula Antimicrobial - F&M , Contents 1000 ml, REMEDY: Bryonia Alba 10X, Antimonium Crudum 10X, Iodium 10X, Ly
Hazard: Out-of-specification test results obtained for identification testing based on HPTLC analysis.
October 6, 2021DrugsFDA
Washington Homeopathic Products, Inc. recalls ZTE-1035 Formula, Antimicrobial Combination, Contents 1006 ml, REMEDY: Arsenicum Album 10X, Baptista Tinctoria 10X, Phos
Hazard: Out-of-specification test results obtained for identification testing based on HPTLC analysis.
October 6, 2021DrugsFDA
Washington Homeopathic Products, Inc. recalls ZTE-1034 Formula Antimicrobial Bowel. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Ars
Hazard: Out-of-specification test results obtained for identification testing based on HPTLC analysis.
October 6, 2021DrugsFDA
Washington Homeopathic Products, Inc. recalls Z-1070 Formula Anxioheal. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY:Caus
Hazard: Out-of-specification test results obtained for identification testing based on HPTLC analysis.
October 6, 2021DrugsFDA
Washington Homeopathic Products, Inc. recalls Z-1050 Formula Hepatodetox. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Cholesterinum
Hazard: Out-of-specification test results obtained for identification testing based on HPTLC analysis.
October 6, 2021DrugsFDA
Washington Homeopathic Products, Inc. recalls Z-1020 Formula. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Aurum Metalli
Hazard: Out-of-specification test results obtained for identification testing based on HPTLC analysis.
October 6, 2021DrugsFDA
Washington Homeopathic Products, Inc. recalls ZTE-1020 Formula. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Aurum Metallicum 10X, C
Hazard: Out-of-specification test results obtained for identification testing based on HPTLC analysis.