🍎 Food Class I - Dangerous
Premature lipid oxidation causing quality issue potentially causing product to have an off odor and bitter taste.
All Recalls
95,094 total recalls in our database
🍎 Food Class I - Dangerous
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
💊 Drugs Class I - Dangerous
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
💊 Drugs Class I - Dangerous
Microbial Contamination of Non-Sterile Products
💊 Drugs Class I - Dangerous
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
💊 Drugs Class I - Dangerous
Microbial contamination of sterile products
💊 Drugs Class I - Dangerous
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
💊 Drugs Class I - Dangerous
Failed Impurities/Degradations Specifications
💊 Drugs Class I - Dangerous
Presence of Particulate matter: Particulate matter identified as glass.
💊 Drugs Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
💊 Drugs Class I - Dangerous
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
💊 Drugs Class I - Dangerous
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: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
INSPIREMD
🏥 Medical Devices Class I - Dangerous
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
🏥 Medical Devices Class I - Dangerous
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
🏥 Medical Devices Class I - Dangerous
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.
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320
Avanos Medical
🏥 Medical Devices Class I - Dangerous
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
🏥 Medical Devices Class I - Dangerous
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320
Avanos Medical
🏥 Medical Devices Class I - Dangerous
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.