Class II · Moderate risk
Vancomycin HCl in Dextrose
Lack of Assurance of Sterility: Sterility of product is not assured.
FDA drug recalls in 2015
Every FDA drug recall initiated in 2015, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,733 recalls, newest first.
Class II · Moderate risk
Penicillin G Potassium 5.4 MU/SW 240 mL AccuFlo
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 2:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class III · Low risk
E-Z-CAT Dry Barium Sulfate for Suspension
Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.
Class III · Low risk
Foradil Aerolizer
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Class III · Low risk
Foradil Aerolizer
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Class II · Moderate risk
Divalproex Sodium Extended-Release Tablets
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Class II · Moderate risk
Divalproex Sodium Extended-Release Tablets
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Class II · Moderate risk
Clarithromycin Tablets
cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure
Class II · Moderate risk
Captopril Tablets
cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure
Class I · High risk
Morphine Sulfate
Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.
Class II · Moderate risk
CONTRAVE (naltrexone HCl and bupropion HCl)
Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components.