Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
All Recalls
95,018 total recalls in our database
Undeclared allergen (soy lecithin).
Taro Cakes UPC CODE #652565100055
E & S Grocery & Bakery
Undeclared Egg Allergen
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Premature lipid oxidation causing quality issue potentially causing product to have an off odor and bitter taste.
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle, Manufactured For: Beekeeper's Naturals USA Inc., Covina, CA 91789.
BEEKEEPER'S NATURALS USA
Microbial Contamination of Non-Sterile Products
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Microbial contamination of sterile products
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)
Fresenius Kabi USA
Failed Impurities/Degradations Specifications
Presence of Particulate matter: Particulate matter identified as glass.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
Brand Name: CGuardΒΏ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
INSPIREMD
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Allia IGS 3 Pulse angiographic X-ray system
GE Medical Systems
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
Bicarby Dialysate; Model number: RFP-400-G;
Fresenius Medical Care Holdings
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.