Every FDA drug recall initiated in 2016, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,199 recalls, newest first.
Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole.
Failed Dissolution Specifications: Out-of-specification results in retained sample.
Failed Dissolution Specifications: Out-of-specification results in retained sample.
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.
Lack of processing controls: Isomeric Pharmacy Solution, LLC is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate 7 mg/mL INJ SUSP because of the potential of drug clumps in the vial of the sterile drug product and larger particle sizes.
Non-Sterility; microbial contamination identified as Bacillus circulans
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
CGMP Deviations
CGMP Deviations
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility