88 recalls · Class III, newest first
Reason Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
Reason Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the…
Reason Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the…
Reason Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Reason Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Reason Subpotent Drug: Low assay result observed during long-term stability testing.
Reason Short Fill: Underfilled units.
Reason Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Reason Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9…