Reason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Distributed: NCReason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Distributed: NCReason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Distributed: NCReason: Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
Distributed: Nationwide and Puerto Rico.Reason: Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
Distributed: Nationwide and Puerto Rico.Reason: Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
Distributed: Nationwide and Puerto Rico.Reason: Presence of Foreign Substance; metal particulates were visually observed in the tablets.
Distributed: NationwideReason: Failed Tablet/Capsule Specifications: There is a potential for broken tablets.
Distributed: Nationwide and Puerto Rico, American Samoa, Virgin Islands, and Canal ZoneReason: Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
Distributed: US Nationwide.Reason: Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Distributed: Nationwide and Puerto Rico