Class I - Dangerous
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Actavis
Class I - Dangerous
Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
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).
Class I - Dangerous
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).
Class I - Dangerous
Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Failed Dissolution Specifications
Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug.
Subpotent Drug: Drug potency was compromised during shipment.
Labeling: Label Error On Declared Strength: Trelstar 11.25 mg labeled carton/kit contained a vial labeled as 3.75 mg instead of a vial being labeled as 11.25mg.
Class I - Dangerous
Failed Tablet/Capsule Specifications: Broken tablets
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
Failed Impurities/Degradation Specifications
Subpotent; some patches may not contain fentanyl gel