Class I - Dangerous
CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx Only, SSM Health Care Corporation, 1015 Bowles, Fenton, MO. NDC 60652-6429-1
SSM Health Care St. Louis
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
Class I - Dangerous
Product Mix-up: Incorrect diluent component included in the kit.
Class I - Dangerous
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
Class I - Dangerous
Labeling: Incorrect Instructions
ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-7087-1
IntegraDose Compounding Services
Class I - Dangerous
Lack of sterility assurance.
Occular Allergy Blend 87% Alcohol; In Equal Parts of Apis Mellifica 7x Allium Cepa 7x Euphrasia Officinalis 7X Sabadilla 7X, WHP Homeopathic Medicine For Manufacturing Only, 500 ml. Manufcatured by Washington Homeopathic Products 260JR Hawvermale Way, Berkeley Springs WV 25411
Washington Homeopathic Products
Class I - Dangerous
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class I - Dangerous
cGMP Deviations
Class I - Dangerous
cGMP Deviations
Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial, Rx only, New Vitalis Pharmacy 4139 Cadillac Ct # 201 Louisville, KY 40213
New Vitalis Pharmacy LLC
Class I - Dangerous
Lack of Assurance of Sterility
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class I - Dangerous
cGMP Deviations
Class I - Dangerous
cGMP Deviations
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class I - Dangerous
cGMP Deviations
Out-of-specification test results obtained for identification testing based on HPTLC analysis.