The latest headlines across every section, pulled from official and open-access sources.
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications — Ascend Laboratories, LLC · Class II · Ongoing
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit. — Asclemed USA Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint. — Lannett Company Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable. — B Braun Medical Inc · Class II · Ongoing
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run. — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · Ongoing
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. — Becton Dickinson & Company · Class I · Ongoing
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection. — B Braun Medical Inc · Class I · Ongoing
Temperature probe devices lack FDA clearance. — Covidien LLC · Class II · Ongoing
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. — Draeger, Inc. · Class I · Ongoing
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable. — B Braun Medical Inc · Class II · Ongoing
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. — Becton Dickinson & Company · Class I · Ongoing
Fingerprint scanner may overheat to a temperature to cause 1st degree burn. — CareFusion 303, Inc. · Class II · Ongoing
Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disenga… — Bayer Medical Care, Inc. · Class II · Ongoing
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run. — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · Ongoing