fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium…
Lack of assurance of sterility:
14,806 recalls, newest first
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:
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:
Lack of assurance of sterility:
Lack of assurance of sterility:
Lack of assurance of sterility:
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Subpotent: Out of Specification result observed for low assay
Incorrect/Undeclared Excipients.
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results