Class II · Moderate risk
Trimix Inj 30:1:20 MDV: 5 ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
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 II · Moderate risk
Trimix Inj 30:1:10 MDV
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
PGE-1 Inj 40mcg/ml MDV
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
PGE-1 Inj 30mcg/ml MDV
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
PGE-1 Inj 20mcg/ml MDV: 5ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
PGE-1 Inj 10mcg/ml MDV
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Papaverine Inj 30mg/ml Syr
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Bimix Inj 30:1 MDV: 5ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Bimix Inj 30:0.5 MDV
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Bimix Inj 30 :1 Syr
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Walmart Amlodipine Besylate Tablets
Labeling: Label Error on Declared Strength-The recalled product has a misprint on the Amoldipine 10 mg label, 5 mg is listed in the USP description. Tablet strength is 10 mg.
Class III · Low risk
Lamisil AT
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Class II · Moderate risk
Glimepiride Tablets USP
Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level.
Class I · High risk
Class II · Moderate risk
Amoxicillin Capsules USP 500 mg
Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.
Class II · Moderate risk
Cyclosporin in Corn Oil Injectable Balanced Solutions
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Class II · Moderate risk
BiMix Customs Injectable Balanced Solutions
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Class II · Moderate risk
Sodium Tetradecyl Sulfate for Injectable Balanced Solutions
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Class II · Moderate risk
HCG Lyophylized Powder 10
Lack of Sterility Assurance
Class II · Moderate risk
Triamcinolone Acetonide Injectable Balanced Solutions
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Class II · Moderate risk
Triamcinolone Diacetate Injectable Balanced Solutions
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Class II · Moderate risk
Bacteriostatic Water for Injection 0.9% Injectable Balanced Solutions
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Class II · Moderate risk
DMSO 50% Sterile Bladder Irrigation Solution Injectable Balanced Solutions
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Class II · Moderate risk
QuadMix Injectable Balanced Solutions
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Class II · Moderate risk
17 Alpha Hydroxyprogesterone Caproate Injectable Balanced Solutions
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.