CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.
All Recalls
95,018 total recalls in our database
Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE GmbH, Germany, Distributed by Hikma Berkeley Heights, NJ 07922, NDC 0143-9299-01
Hikma Pharmaceuticals USA
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Failed impurities/degradation specifications: Out of specification for unknown impurities.
Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.
Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)
Remington Medical
The stylet is longer than specified on the label
Pilling Wecksorb Cylindrical Sponges
TELEFLEX
Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.
Distribution without Pre-Market Clearance
Distribution without Pre-Market Clearance
Distribution without Pre-Market Clearance
Distribution without Pre-Market Clearance
Body Glove Tandem Inflatable Stand Up Paddle Board, ULI Inventor Inflatable Paddle Board, ULI Zettian Inflatable Supyak and ULI Lila Inflatable Supyak
Jiangxi Aike Outdoor Sports, of China
The glue on the inflatable paddle boards can separate at the seams and the paddle boards can deflate unexpectedly, posing a drowning hazard.
Yamaha Viking Off-Road Side-by-Side vehicles
Yamaha Motor Manufacturing Corp. of America, of Newnan, Georgia
Improper installation of the retaining bolts could result in the parking brake mechanism failing to hold the vehicle when parked allowing the vehicle to move unintentionally, posing crash and injury hazards.
ZLINE 30-inch and 36-inch RG gas ranges
Unknown Manufacturer
The oven of the gas ranges can emit dangerous levels of carbon monoxide (CO) while in use, posing a serious risk of injury or death from carbon monoxide poisoning.
22 oz Blonde; 20 oz Blonde EZ; 24 oz Blonde EZ frozen pizza dough manufactured by It'll Be Pizza
It'll Be Pizza
Product may be contaminated with foreign object (debris from packaging).
Pies labeled as Red Button French Silk may contain Turtle Cream Pies containing almonds which are not declared on the French Silk label.
EGA 22 oz Pizza Dough Ball, 20 ct/ case; frozen pizza dough
It'll Be Pizza
Product may be contaminated with foreign object (debris from packaging).
Gamesa Arcoiris Marshmallow Cookies, Naturally and Artificially Flavored 15.5 Oz, 6 Count UPC 6 86700 10132 4
Comercializadora Pepsico Mexico,
Potential to contain Salmonella
Product may be contaminated with foreign object (debris from packaging).
Product may be contaminated with foreign object (debris from packaging).
Product may be contaminated with foreign object (debris from packaging).