Prescription and over-the-counter medications
Olympia Compounding Pharmacy
Lack of assurance of sterility.
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Subpotent drug: Low OOS for menthol content at the three month room temperature.
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions
Microbial Contamination of Non-Sterile Products
Microbial Contamination of Non-Sterile Products
CGMP Deviations: Failure to properly investigate failed microbial testing.
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
CGMP Deviations: Failure to properly investigate failed microbial testing.
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
CGMP Deviations: Failure to properly investigate failed microbial testing.
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Lupin Pharmaceuticals
Failed Stability Specification
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Lula Holdings L.L.C.
CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.
Subpotent Drug
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.