CGMP Deviation: impurities exceed allowable limits.
⚗️
Compounded Drugs
💊 Drugs • 1,903 recalls
Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013. NDC: 74663-002-01
Jarman's Midwest Cleaning Systems
Class I - Dangerous
CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.
SOFT HANDS Alcohol Antiseptic 80%, Topical Solution, HAND SANITIZER, NON-STERILE SOLUTION, cleanpro SUPPLY, 1 US gallon / 3785.41ml, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013.
Jarman's Midwest Cleaning Systems
Class I - Dangerous
Chemical Contamination: FDA testing found Presence of methanol
Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013.
Jarman's Midwest Cleaning Systems
Class I - Dangerous
Chemical Contamination: FDA testing found Presence of methanol
Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class I - Dangerous
Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution, 4fl. oz. [118mL], Distributed by Reliable Products, LLC, Cheyenne, WY 82003, NDC 75288-100-04.
Nanomaterials Discovery
Class I - Dangerous
Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.
Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82
Denver Solutions, LLC
Class I - Dangerous
CGMP DEVIATIONS
CEFOXITIN (a) 1GM IN NS 50ML,(b) 2GM IN NS 100ML, used with a home pump. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Sentara Infusion Services
Class I - Dangerous
Lack of sterility assurance
CEFEPIME, (a) 2GM IN NS 100ML (b)8GM IN NS 400ML (c) 12GM IN NS 600ML, used with a Curlin or Home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Sentara Infusion Services
Class I - Dangerous
Lack of sterility assurance
AMPICILLIN 8GM IN NS 400ML, antibiotic, used with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Sentara Infusion Services
Class I - Dangerous
Lack of sterility assurance
Class I - Dangerous
Lack of sterility assurance
CEFAZOLIN 5mg/mL/HEPARIN 100unit/ml 1.5ML SYR, antibiotic, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Sentara Infusion Services
Class I - Dangerous
Lack of sterility assurance
D5 NS 2300ML, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Sentara Infusion Services
Class I - Dangerous
Lack of sterility assurance
CEFTRIAXONE (a) 2GM in NS 100ml, (b) 4GM IN NS 200ML, Antibiotic, used with a Curlin or Home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Sentara Infusion Services
Class I - Dangerous
Lack of sterility assurance
Class I - Dangerous
Lack of sterility assurance
D5W1/2NS W/ 77MEQ OF SOD ACETATE 1000ML, Hydration, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Sentara Infusion Services
Class I - Dangerous
Lack of sterility assurance
CASPOFUNGIN 50MG IN NS 100ML, used with a HOMEPUMP, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Sentara Infusion Services
Class I - Dangerous
Lack of sterility assurance
ETHANOL 70% 0.5ML SYRINGE, Cathcare, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Sentara Infusion Services
Class I - Dangerous
Lack of sterility assurance
AMPICILLIN 12GM IN NS 600M, used with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Sentara Infusion Services
Class I - Dangerous
Lack of sterility assurance