🍎 Food Class I - Dangerous
Allergen not listed in the Contains statement: Fish
All Recalls
95,114 total recalls in our database
🍎 Food Class I - Dangerous
Products contain undeclared sub ingredients: wheat and milk
🍎 Food Class I - Dangerous
Products contain undeclared sub ingredient: wheat.
54th St Blackened Sauce, 9lb bags - 4 bags per case.
La Fontanella Food Products
🍎 Food Class I - Dangerous
Soy is in the ingredients but missing from the contains statement.
Blueberry Scones, bulk packaged in cake boxes with parchment paper, unwrapped. Products are not individual labeled and are held in bulk for retail sale. Each location has a notebook with all the ingredients used in the scones.
Skagit River Bakery & Cafe
🍎 Food Class I - Dangerous
Undeclared soy lecithin and soybean oil on label
🍎 Food Class I - Dangerous
Products contain undeclared sub ingredient: wheat.
🍎 Food Class I - Dangerous
Products contain undeclared wheat.
🍎 Food Class I - Dangerous
Undeclared allergen (Fish) Ingredient
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications
EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1
EnviroServe Chemicals
💊 Drugs Class I - Dangerous
CGMP deviations
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
💊 Drugs Class I - Dangerous
Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
💊 Drugs Class I - Dangerous
Microbial Contamination of Non-Sterile Product
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06
Mckesson Medical-Surgical Inc. Corporate Office
💊 Drugs Class I - Dangerous
Temperature abuse: Products exposed to improper temperature above drug label specifications.
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, 07430, NDC 68462-180-22.
Glenmark Pharmaceuticals Inc., USA
💊 Drugs Class I - Dangerous
Subpotent Drug
Pacemaker, COPM11B; Medical convenience kit
American Contract Systems
🏥 Medical Devices Class I - Dangerous
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
🏥 Medical Devices Class I - Dangerous
Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
🏥 Medical Devices Class I - Dangerous
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.