Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10) recall — FDA D-1293-2020
Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
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Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Presence of Particulate Matter: particulate matter identified after reconstitution.
Presence of Particulate Matter - found in reserve sample vials at the firm.
Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
Subpotent drug - Product did not contain drug.
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
Presence of Particulate Matter - found in reserve sample vials at the firm.
BMW of North America, LLC (BMW) is recalling certain 2019 Z4 sDrive30i, 2019-2020 330i xDrive, M340i and M340i xDrive, 2020 X3M and X4M, and Toyota Supra vehicles. In certain driving…
Mazda North American Operations (Mazda) is recalling certain 2020 CX-30 vehicles equipped with all-wheel drive. The evaporative vent hose for the fuel tank may be disconnected, possibly…
Mazda North American Operations (Mazda) is recalling certain 2020 CX-30 and Mazda3 vehicles. The front brake caliper mounting bolts may not have been tightened properly during assembly,…
The surgical gowns were manufactured in a facility that is not registered by the FDA.
The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.
After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the correct amout of IOB before…
There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
Packaged dental implant healing abutments were found to contain the wrong size device.
In the case of an AQM clot detection error a portion of the distilled water from the Aliquoter Module hydraulic circuit may be dispensed into the Primary Tube leading to sample dilution,…
There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.
There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible
The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming non-functional.
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