Class II · Moderate risk Terminated
Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml…
Reason Lack of sterility assurance.
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV…
Reason Lack of sterility assurance.
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 I · High risk Terminated
7K capsules packaged in single packs sold in 24-count boxes
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Class I · High risk Terminated
POSEIDON Xtreme PLATINUM 4500
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
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.