Drug recalls
Recalls
-
One Source Nutrition, Inc, drug recall: Vitality
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
-
Central Admixture Pharmacy Services, Inc. drug recall: PHENYLephrine added to 0.9% sodium chloride
Presence of Particulate Matter
-
CareFusion 213, LLC drug recall: BD ChloraPrep Clear 1mL Applicators
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
-
ICU Medical, Inc. drug recall: POTASSIUM CHLORIDE Inj
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct…
-
Alvogen, Inc drug recall: Fentanyl Transdermal System CII
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
-
Provepharm Inc. drug recall: Phenylephrine HCl Injection
Presence of Particulate Matter.
-
ENDO USA, Inc. drug recall: Adrenalin Chloride Solution
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
-
Astellas Pharma US Inc. drug recall: Astagraf XL
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
-
Shoppers- Plaza drug recall: FOUZEE SugarLin HERBAL FORMULA capsules
Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
-
Alcon Research LLC drug recall: Systane Lubricant Eye Drops
Non-Sterility
-
Buy-Herbal drug recall: Nhan Sam Tuyet Lien Truy Phong Hoan
Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine
-
Endo USA, Inc. drug recall: Clonazepam Orally Disintegrating Tablet
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
-
GNMart LLC drug recall: FORCE FOREVER 400mg Tablets
Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.