Two food trailers holding various types and brands of frozen foods were temperature abused during deliver to two retail stores.
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Two food trailers holding various types and brands of frozen foods were temperature abused during deliver to two retail stores.
Two food trailers holding various types and brands of frozen foods were temperature abused during deliver to two retail stores.
Two food trailers holding various types and brands of frozen foods were temperature abused during deliver to two retail stores.
🍎 Food Class I - Dangerous
Two food trailers holding various types and brands of frozen foods were temperature abused during deliver to two retail stores.
Two food trailers holding various types and brands of frozen foods were temperature abused during deliver to two retail stores.
💊 Drugs Class I - Dangerous
Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India.
Glenmark Pharmaceuticals Inc., USA
💊 Drugs Class I - Dangerous
Defective Container: Tube split from side seam
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications: below specification limits for dissolution.
💊 Drugs Class I - Dangerous
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications: below specification limits for dissolution.
SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.
Ultra Supplement
💊 Drugs Class I - Dangerous
Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
Merlin 2 PCS MER37000 programmer Model MER3400 software
St. Jude Medical, Cardiac Rhythm Management Division
🏥 Medical Devices Class I - Dangerous
The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.
Merlin PCS 3650 programmer Model 3330 software
St. Jude Medical, Cardiac Rhythm Management Division
🏥 Medical Devices Class I - Dangerous
There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.
PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Aesculap Implant Systems
🏥 Medical Devices Class I - Dangerous
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
NanoSight NS300
MALVERN PANALYTICAL
🏥 Medical Devices Class I - Dangerous
Product found to not comply to Class 1 Laser safety requirement.
CustMbite, Model Number CBT-SRS-UL
Dental Choice Holding
🏥 Medical Devices Class I - Dangerous
The device was marketed and sold in the US without FDA clearance.
PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
Aesculap Implant Systems
🏥 Medical Devices Class I - Dangerous
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
🏥 Medical Devices Class I - Dangerous
Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems.
Craftmatic Model 1 Base for Dual Bed Configurations
Craftmatic Industries
🏥 Medical Devices Class I - Dangerous
A potential for dual-configured beds to separate or slip away from one another.