All Recalls

Labeling: Label Mix-Up.The recall has been initiated after receiving one complaint about incorrect labeling.The primary label on the front and back label on some of the bottles have 70% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces

Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.

Lack of processing controls

Failed Impurities/Degradation Specifications

Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine

Lack of Assurance of Sterility

Superpotent Drug

Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.

Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle

CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain methanol.

Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.

Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families

Product may not perform as specified in IFU.

Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBTs (insulated-gate bipolar transistor) of the ADU. The overheating may generate a peculiar burning smell that may be noticed. In some instances, this burning smell may be noticed before the ADU fails. When the ADU fails the X-ray performance of the system is reduced to Emergency Fluoroscopy. Exposure will not be possible and image quality will be reduced.

The firm has identified a potential for the backrest to become detached from the chair.

Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.

The kit does not have an emergency use authorization (EUA).

Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.

Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.

Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families