March 8, 2023DrugsFDA
DuPont Nutrition USA, Inc recalls Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. Net Content/Gross Weight 50.0 KG / 54.5 KG bulk contain
Hazard: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
March 1, 2023DrugsFDA
RISING PHARMACEUTICALS recalls Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663
Hazard: Failed Impurities/Degradation Specifications
March 1, 2023DrugsFDA
B. Braun Medical Inc. recalls 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, ND
Hazard: Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.
March 1, 2023DrugsFDA
B. Braun Medical Inc. recalls 0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, N
Hazard: Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.
March 1, 2023DrugsFDA
IBSA PHARMA INC recalls TIROSINT - SOL (levothyroxine sodium) Oral Solution, 200 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for
Hazard: Subpotent Drug
March 1, 2023DrugsFDA
IBSA PHARMA INC recalls TIROSINT - SOL (levothyroxine sodium) Oral Solution, 150 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for
Hazard: Subpotent Drug
March 1, 2023DrugsFDA
IBSA PHARMA INC recalls TIROSINT - SOL (levothyroxine sodium) Oral Solution, 137 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for
Hazard: Subpotent Drug
March 1, 2023DrugsFDA
IBSA PHARMA INC recalls TIROSINT - SOL (levothyroxine sodium) Oral Solution, 112 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for
Hazard: Subpotent Drug
March 1, 2023DrugsFDA
IBSA PHARMA INC recalls TIROSINT - SOL (levothyroxine sodium) Oral Solution, 88 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for I
Hazard: Subpotent Drug
March 1, 2023DrugsFDA
IBSA PHARMA INC recalls TIROSINT - SOL (levothyroxine sodium) Oral Solution, 75 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for I
Hazard: Subpotent Drug
March 1, 2023DrugsFDA
IBSA PHARMA INC recalls TIROSINT - SOL (levothyroxine sodium) Oral Solution, 62.5 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for
Hazard: Subpotent Drug
March 1, 2023DrugsFDA
IBSA PHARMA INC recalls TIROSINT - SOL (levothyroxine sodium) Oral Solution, 50 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for I
Hazard: Subpotent Drug
March 1, 2023DrugsFDA
IBSA PHARMA INC recalls TIROSINT - SOL (levothyroxine sodium) Oral Solution, 44 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for
Hazard: Subpotent Drug
March 1, 2023DrugsFDA
IBSA PHARMA INC recalls TIROSINT - SOL (levothyroxine sodium) Oral Solution, 37.5 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for
Hazard: Subpotent Drug
March 1, 2023DrugsFDA
IBSA PHARMA INC recalls TIROSINT - SOL (levothyroxine sodium) Oral Solution, 25 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for I
Hazard: Subpotent Drug
March 1, 2023DrugsFDA
IBSA PHARMA INC recalls TIROSINT - SOL (levothyroxine sodium) Oral Solution, 175 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for
Hazard: Subpotent Drug
March 1, 2023DrugsFDA
IBSA PHARMA INC recalls TIROSINT - SOL (levothyroxine sodium) Oral Solution, 125 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for
Hazard: Subpotent Drug
March 1, 2023DrugsFDA
IBSA PHARMA INC recalls TIROSINT - SOL (levothyroxine sodium) Oral Solution, 100 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for
Hazard: Subpotent Drug
March 1, 2023DrugsFDA
IBSA PHARMA INC recalls TIROSINT - SOL (levothyroxine sodium) Oral Solution, 13 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for I
Hazard: Subpotent Drug
March 1, 2023DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500
Hazard: Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
March 1, 2023DrugsFDA
Advantice Health, Llc recalls Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% First aid antiseptic, Benzocaine 20%) Topical analg
Hazard: Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
February 22, 2023DrugsFDA
Amerisource Health Services LLC recalls BuPROPion Hydrochloride Tablets, USP 75 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health P
Hazard: Failed Impurities/Degradation Specifications
February 22, 2023DrugsFDA
Leadiant Biosciences, Inc. recalls Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianap
Hazard: Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
February 22, 2023DrugsFDA
Consolidated Chemical, Inc recalls Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139.
Hazard: CGMP Deviations: initiated due to violations of CGMP manufacturing practices
February 22, 2023DrugsFDA
Consolidated Chemical, Inc recalls Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle, Care-Tech Laboratories, Inc., Saint Louis
Hazard: CGMP Deviations: initiated due to violations of CGMP manufacturing practices
February 22, 2023DrugsFDA
Sentara Infusion Services recalls VITAMIN K(PHYTONADIONE) 2.5MG(0.25ML) SYRINGE, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy,
Hazard: Lack of sterility assurance
February 22, 2023DrugsFDA
Sentara Infusion Services recalls VANCOMYCIN (a)700 MG NS 140ML, (b) 1000MG IN NS 200ML, abtibiotic, Rx only, use with home pump, Sentara Home Infusion Ph
Hazard: Lack of sterility assurance
February 22, 2023DrugsFDA
Sentara Infusion Services recalls Vancomycin (a) 1.25GM IN NS 250ML, (b) 1.5GM IN NS 300ML, (c) 1000MG IN NS 200ML (d) 2GM IN 400ML NS, (e) 900MG IN NS
Hazard: Lack of sterility assurance
February 22, 2023DrugsFDA
Sentara Infusion Services recalls TPN (a) 95GM/AA, 385/DEX, 50GM/LIP 1800ML, (b)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (c) TPN: AA 80GM ; DEX 320GM ; LIP
Hazard: Lack of sterility assurance
February 22, 2023DrugsFDA
Sentara Infusion Services recalls TPN (a) 115GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (b)90GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (c) TPN AA: 100GM DEX: 105GM 2700M
Hazard: Lack of sterility assurance