Class II · Moderate risk
Zileuton Extended-Release Tablets
Failed Dissolution Specifications: Out of specification result for dissolution.
FDA drug recalls in 2019
Every FDA drug recall initiated in 2019, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,788 recalls, newest first.
Class II · Moderate risk
ZYFLO CR (zileuton)
Failed Dissolution Specifications: Out of specification result for dissolution.
Class II · Moderate risk
Trisodium Citrate 0.5% CRRT SOLUTION. RX Only. Rx # specific and…
Lack of sterility assurance.
Class II · Moderate risk
Memorial Central TPN. Rx Only
Lack of sterility assurance.
Class II · Moderate risk
Sn-Pyrophosphate Kit
Lack of Processing Controls.
Class II · Moderate risk
Sn-Tetrofosmin Kit 5.0 mL
Lack of Processing Controls.
Class II · Moderate risk
Sn-DTPA Kit 10 mg
Lack of Processing Controls.
Class II · Moderate risk
Sn-d
Lack of Processing Controls.
Class II · Moderate risk
Sulfur Colloid Reaction Vial 1.0 mL
Lack of Processing Controls.
Class II · Moderate risk
Sn-Mertiatide Kit
Lack of Processing Controls.
Class II · Moderate risk
Sn-DMSA solution
Lack of Processing Controls.
Class II · Moderate risk
Pentreotide
Lack of Processing Controls.
Class I · High risk
Pecgen DMX Cough Suppressant Expectorant
Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician. The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age.
Class II · Moderate risk
Trimix 30mg/1 mg/10mcg/mL
Lack of Sterility Assurance.
Class II · Moderate risk
Testosterone Cypionate 200 mg/mL
Lack of Sterility Assurance.
Class II · Moderate risk
Testosterone Cyp/Pro 95/5%
Lack of Sterility Assurance.
Class II · Moderate risk
Testosterone 200 mg/mL
Lack of Sterility Assurance.
Class II · Moderate risk
Sermorelin/GHRP-2 &6
Lack of Sterility Assurance.
Class II · Moderate risk
Sermorelin/GHRP-2 &6
Lack of Sterility Assurance.
Class II · Moderate risk
Sermorelin/GHRP-2 & 6
Lack of Sterility Assurance.
Class II · Moderate risk
Sermorelin/GHRP-2 9 mg/6 mg vials
Lack of Sterility Assurance.
Class II · Moderate risk
Sermorelin/GHRP-2 9 mg/9 mg vials Pharm D. Solutions 1304 South Loop West
Lack of Sterility Assurance.
Class II · Moderate risk
Sermorelin/Ipamorelin 18 mg/15 mg
Lack of Sterility Assurance.
Class II · Moderate risk
Nandrolone Decanoate 200 mg/mL Injectable
Lack of Sterility Assurance.
Class II · Moderate risk
Lipo MIC-12
Lack of Sterility Assurance.