Class II · Moderate risk Terminated
Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV…
Reason Lack of sterility assurance.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Methylene Blue 10 mg/mL 1ml. Packaged in 1 mL syringes…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Magnesium Sulfate 200 mg/mL
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Glutathione 200 mg/mL 100ml. Rx Only. Packaged in 100 mL MDV…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
My Way
Reason Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Class II · Moderate risk Terminated
My Way
Reason Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Class II · Moderate risk Terminated
Option Systems Antibacterial Foaming Hand Wash with .3% PCMX
Reason Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts
Class II · Moderate risk Terminated
screamin' menthol
Reason CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Class II · Moderate risk Terminated
screamin' hot
Reason CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Class II · Moderate risk Terminated
Silver-Zinc Throat Spray
Reason Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
Class II · Moderate risk Terminated
Argentum Elixir Colloidal Silver
Reason Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.