1,523 recalls · Class III, newest first
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
Reason Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Reason Failed Content Uniformity Specifications
Reason Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related…
Reason Subpotent Drug
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
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 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…
Reason Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Reason Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf…
Reason Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Reason Failed dissolution specifications
Reason Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Reason Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Reason Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.