Drug recalls
627 recalls
TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%)
Blaine Labs Inc
CGMP Deviations;
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG)…
CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth…
Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule
Asclemed USA Inc.
Lack of Assurance of Sterility
IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL)
ACCORD BIOPHARMA INC
Lack of assurance of Sterility:
BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and…
CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth…
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate
Lannett Company Inc.
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER…
Synjardy XR Tablets (empagliflozin and metformin hydrochloride exte…
Boehringer Ingelheim Pharmaceuticals, Inc.
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed…
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg)
ACCORD HEALTHCARE, INC.
Subpotent Drug
BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) wit…
CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth…
TRIFLUENT PHARMA TRIDERGEL Wound Care Gel
Blaine Labs Inc
CGMP Deviations: product manufactured in the same facility under the same conditions as the produ…
TERPENICOL Antifungal Cream (Undecylenic Acid 13%)
Blaine Labs Inc
CGMP Deviations;
prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile
Lupin Pharmaceuticals Inc.
Presence of Foreign Substance
Revitaderm Wound Care, First Aid Antiseptic Gel
Blaine Labs Inc
CGMP Deviations;
BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and…
CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth…
vite20 Antifungal Cream, (10% Undecylenic Acid)
Blaine Labs Inc
CGMP Deviations;
Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL)
McKesson
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment in…
Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%
Blaine Labs Inc
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus…
BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70%…
CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth…
Prednisolone Acetate Ophthalmic Suspension, USP
Lupin Limited
Presence of a foreign substance found in the eye drops.
Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only
Amgen, Inc.
Presence of Foreign Substance.
Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only
Amgen, Inc.
CGMP Deviations
DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps
Direct Rx
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Corlanor (ivabradine) tablets, 5 mg
Amgen, Inc.
Presence of Foreign Substance.
BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v…
CareFusion 213, LLC
Non-Sterility: Due to presence of Aspergillus penicillioides.
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag
Central Admixture Pharmacy Services, Inc.
Incorrect product formulation: bag did not contain copper and famotidine per label.
PReye Vitamin See Antioxidant Preservative Free Eye Drops
PReye LLC
Lack of Assurance of Sterility
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and…
CareFusion 213, LLC
Non-Sterility: Due to presence of Aspergillus penicillioides.
Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle
Annora Pharma Private Limited
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet i…
Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules
Ajanta Pharma USA Inc
CGMP Deviations
BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) an…
CareFusion 213, LLC
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal…