February 22, 2023DrugsFDA
Sentara Infusion Services recalls Diphenhydramine 18mg in 3.6ML NS SYRINGE, antihistamine, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independe
Hazard: Lack of sterility assurance
February 22, 2023DrugsFDA
Sentara Infusion Services recalls Dextrose 10% 720ML, TPN, Rx only, use with a home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy,
Hazard: Lack of sterility assurance
February 22, 2023DrugsFDA
Sentara Infusion Services recalls DAPTOMYCIN (a) 400MG IN NS 20ML, (b) 550MG IN NS 27.5ML, antibiotic, Rx only, used with a home pump. Sentara Home Infusi
Hazard: Lack of sterility assurance
February 22, 2023DrugsFDA
Sentara Infusion Services recalls DAPTOMYCIN (a)360MG in NS 18ML syringe (b)580MG IN NS 29ML syringe(c) 630MG IN NS 31.5ML used with a home pump; antibio
Hazard: Lack of sterility assurance
February 22, 2023DrugsFDA
Sentara Infusion Services recalls D5W1/2NS W/ 77MEQ OF SOD ACETATE 1000ML, Hydration, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste
Hazard: Lack of sterility assurance
February 22, 2023DrugsFDA
Sentara Infusion Services recalls D5 NS 2300ML, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Hazard: Lack of sterility assurance
February 22, 2023DrugsFDA
Sentara Infusion Services recalls CEFTRIAXONE (a) 2GM in NS 100ml, (b) 4GM IN NS 200ML, Antibiotic, used with a Curlin or Home pump, Sentara Home Infusion
Hazard: Lack of sterility assurance
February 22, 2023DrugsFDA
Sentara Infusion Services recalls CEFTRIAXONE (a) 1GM IN NS 50ML, (b)4GM IN NS 200ML, (c) 8GM IN NS 400ML, antibiotic, Rx only, used in a Curlin or Home
Hazard: Lack of sterility assurance
February 22, 2023DrugsFDA
Sentara Infusion Services recalls CEFOXITIN (a) 1GM IN NS 50ML,(b) 2GM IN NS 100ML, used with a home pump. Sentara Home Infusion Pharmacy Services, 535 In
Hazard: Lack of sterility assurance
February 22, 2023DrugsFDA
Sentara Infusion Services recalls 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 Inf
Hazard: Lack of sterility assurance
February 22, 2023DrugsFDA
Sentara Infusion Services recalls CEFAZOLIN 5mg/mL/HEPARIN 100unit/ml 1.5ML SYR, antibiotic, Sentara Home Infusion Pharmacy Services, 535 Independence Pkw
Hazard: Lack of sterility assurance
February 22, 2023DrugsFDA
Sentara Infusion Services recalls CEFAZOLIN (a) 12GM IN NS 600ML, (b) 2GM IN NS 100ML, (c) 2GM/20ML SW SYRINGE, (d) 3GM IN NS 150ML, antibiotic, used with
Hazard: Lack of sterility assurance
February 22, 2023DrugsFDA
Sentara Infusion Services recalls CASPOFUNGIN 50MG IN NS 100ML, used with a HOMEPUMP, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste
Hazard: Lack of sterility assurance
February 22, 2023DrugsFDA
Sentara Infusion Services recalls Ampicillin/Sulbactam 3GM IN NS 100ML, antibiotic, Rx only, used with a home pump, Sentara Home Infusion Pharmacy Service
Hazard: Lack of sterility assurance
February 22, 2023DrugsFDA
Sentara Infusion Services recalls AMPICILLIN 8GM IN NS 400ML, antibiotic, used with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence
Hazard: Lack of sterility assurance
February 22, 2023DrugsFDA
Sentara Infusion Services recalls AMPICILLIN 12GM IN NS 600M, used with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste
Hazard: Lack of sterility assurance
February 22, 2023DrugsFDA
Sentara Infusion Services recalls Amikacin 450MG IN NS 45ML, Antibiotic, used in a HOMEPUMP, Sentara Home Infusion Pharmacy Services, 535 Independence Pkw
Hazard: Lack of sterility assurance
February 22, 2023DrugsFDA
Sentara Infusion Services recalls 0.9% Sodium Chloride, used as a diluent or hydration, packaged volume of (a)1000ML (b)2000ML (c) 720ML, used with Curli
Hazard: Lack of sterility assurance
February 22, 2023DrugsFDA
HTO Nevada, Inc. recalls Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL SOURCE, P
Hazard: cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
February 22, 2023DrugsFDA
HTO Nevada, Inc. recalls New & Improved Blue Gel Anesthetic, to reduce pain and swelling during pain sensitive procedures, 1 oz bottle, distribut
Hazard: cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
February 22, 2023DrugsFDA
Amerisource Health Services LLC recalls Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-c
Hazard: Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.
February 22, 2023DrugsFDA
McGuff Compounding Pharmacy Services, Inc. recalls Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW IN
Hazard: Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
February 22, 2023DrugsFDA
McGuff Compounding Pharmacy Services, Inc. recalls Thiamine Hydrochloride 200 mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVEN
Hazard: Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
February 15, 2023DrugsFDA
BIOCON PHARMA INC recalls Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ
Hazard: Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
February 15, 2023DrugsFDA
Akorn, Inc. recalls Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distrib
Hazard: Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
February 15, 2023DrugsFDA
Urban Electric Power recalls Ohm Sanitizer Spray (alcohol (ethyl alcohol) 80% v/v, 8 FL OZ (237 ML) bottles.
Hazard: CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
February 15, 2023DrugsFDA
Urban Electric Power recalls Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 ML), b) 3 FL OZ (88 ML) bottles, c) 10 FL OZ
Hazard: CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
February 8, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles, Manufactured by: Sun Pharmace
Hazard: Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
February 8, 2023DrugsFDA
DISCOVERY PHARMA LLC recalls Conzerol zero molluscum contagiosum, Homeopathic treatment for Molluscum Contagiosum, Topical Cream, Net weight 0.78 oz
Hazard: CGMP deviations
February 8, 2023DrugsFDA
Frenda Corporation recalls Global Care 70% Alcohol Ethyl Rubbing Alcohol, packaged in a) 32 FL OZ (946 mL) UPC 8 70373 01323 1; b) 16 FL OZ (473 mL
Hazard: cGMP Deviations