Prescription Drugs

Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.

Subpotent Drug; 15-month stability test station

Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.

Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.

Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.

Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes