Class II · Moderate risk
Risperdal CONSTA
Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample
FDA drug recalls in 2013
Every FDA drug recall initiated in 2013, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
2,085 recalls, newest first.
Class III · Low risk
Loratadine 24 HR-OTC
Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.
Class III · Low risk
Timolol Maleate Sterile Ophthalmic Solution
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Class III · Low risk
Timolol Maleate Sterile Ophthalmic Solution
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Class III · Low risk
Timolol Maleate Sterile Ophthalmic Solution
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Class III · Low risk
Timolol Maleate Sterile Ophthalmic Solution
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Class III · Low risk
Ofloxacin Ophthalmic Solution
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Class III · Low risk
Ofloxacin Ophthalmic Solution
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Class II · Moderate risk
Vancomycin PF
Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.
Class II · Moderate risk
Bevacizumab 1.25 mg/0.05 mL PF
Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.
Class III · Low risk
Derma-Smoothe/FS
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
Derma-Smoothe/FS
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class II · Moderate risk
Concentrated Motrin
Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed
Class II · Moderate risk
SIH-Testosterone Cypionate 200 mg/mL Injectable
Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory
Class II · Moderate risk
Estradiol 1.25 mg
Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory.
Class I · High risk
Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution
Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact that the preservative used in the lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution may not be effective through expiry.
Class II · Moderate risk
Histamine
Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Class II · Moderate risk
Sodium Phosphate Injectable
Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Class II · Moderate risk
Pge-1
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Class II · Moderate risk
Pge-1
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Class II · Moderate risk
Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL Injection
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Class II · Moderate risk
Testosterone CYP
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Class II · Moderate risk
Testosterone Cypionate
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Class II · Moderate risk
0.5% Bupivacaine HCl and Epinephrine 1:200
Lack of Assurance of Sterility; potential for vial breakage
Class II · Moderate risk
Bevacizumab 25mg/mL
Lack of Assurance of Sterility: Fallon Pharmacy recalled Bevacizumab 25mg/mL due to sterility assurance concerns based on testing of this lot by a third party lab, indicating that test results reported as passing sterility may have been inaccurate.