Complete FDA and NHTSA recall records dated in August 2018.
These records include useful source details for the selected month.
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
API material used in the manufacturing of the product did not receive regulatory approval prior to release.
Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Volvo Cars USA LLC (Volvo) is recalling certain 2019 Volvo XC40 vehicles. The rear seats may not have rear seat back lock strikers, allowing the seat back to move forward during certain…
Chrysler (FCA US LLC) is recalling certain 2018 Jeep Renegade, Compass and Grand Cherokee, RAM 1500 and Promaster, Fiat 500x, Dodge Journey, Challenger, Charger and Durango and Chrysler…
Chrysler (FCA US LLC) is recalling certain 2018-2019 Dodge Grand Caravan and Jeep Compass, 2018 Dodge Journey, and 2019 Jeep Cherokee vehicles. The rear brake caliper pistons on these…
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can…
The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can…
The device is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. IQC that is reported as out…
There were instances where the power cord socket detached from the back of the AMIA cycler when the power cord was unplugged from the socket.
Product contains dry natural rubber latex. Label states Latex Free.
Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
