All Recalls

Lack of Assurance of Sterility

Lack of Assurance of Sterility

CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.

Lack of Assurance of Sterility

Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.

Lack of Assurance of Sterility

Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis

Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Failed Dissolution Specifications

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.

CGMP Deviations: OTC products were stored outside of labeled temperature requirements.