Prescription and over-the-counter medications
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.
Failed Dissolution Specifications: low out of specification results for dissolution.
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Subpotent Drug
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Subpotent Drug
Defective container: loose crimp defect, potential loss of container integrity.
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.
Subpotent Drug
Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
Subpotent Drug
Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
SCA Pharmaceuticals
CGMP Deviations