All 4-aminopyridine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
Reliable Rexall-A Compounding Pharmacy
Lack of Processing Controls
Prescription and over-the-counter medications
Reliable Rexall-A Compounding Pharmacy
Lack of Processing Controls
Reliable Rexall-A Compounding Pharmacy
Lack of Processing Controls
Cantrell Drug Company
Subpotent Drug
Reliable Rexall-A Compounding Pharmacy
Lack of Processing Controls
Reliable Rexall-A Compounding Pharmacy
Lack of Processing Controls
Reliable Rexall-A Compounding Pharmacy
Lack of Processing Controls
Reliable Rexall-A Compounding Pharmacy
Lack of Processing Controls
Cantrell Drug Company
Stability Data Does Not Support Expiry
Allergan Sales
Failed Content Uniformity Specifications.
Bee Extremely Amazed
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.
Reliable Rexall-A Compounding Pharmacy
Lack of Processing Controls
Reliable Rexall-A Compounding Pharmacy
Lack of Processing Controls
Vital Care Compounder
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vial on all containers.
Reliable Rexall-A Compounding Pharmacy
Lack of Processing Controls
Cantrell Drug Company
Subpotent Drug
Reliable Rexall-A Compounding Pharmacy
Lack of Processing Controls
Reliable Rexall-A Compounding Pharmacy
Lack of Processing Controls
Cantrell Drug Company
Subpotent Drug
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the expiration (24-month).