US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

Class II · Moderate risk Terminated

Blephamide

Reason Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Allergan Sales, LLC NDC 0023-0313-04 D-1820-2015
Class II · Moderate risk Terminated

FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx…

Reason Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Allergan Sales, LLC NDC 0023-0316-04 D-1819-2015
Class II · Moderate risk Terminated

Refresh P.M.

Reason Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Allergan Sales, LLC NDC 0023-0240-04 D-1818-2015
Class II · Moderate risk Terminated

Refresh Lacri-Lube

Reason Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Allergan Sales, LLC NDC 0023-0312-04 D-1817-2015
Class II · Moderate risk Terminated

Doxycycline Hyclate Tablets

Reason Labeling: Wrong Bar Code

C. O. Truxton NDC 0463-6000-50 D-0164-2016
Class II · Moderate risk Terminated

Ketamine Hydrochloride Injection

Reason Defective Container: There were customer complaints of cracked and leaking glass vials.

Hospira Inc. NDC 00409-2051-05 D-0418-2015
Class II · Moderate risk Terminated

Lidocaine HCI

Reason Stability data does not support expiry.

Pharmakon Pharmaceuticals D-0604-2016
Class II · Moderate risk Terminated

Ketamine 50 mg/mL

Reason Stability data does not support expiry.

Pharmakon Pharmaceuticals D-0602-2016
Class II · Moderate risk Terminated

Morphine Sulfate

Reason Stability data does not support expiry.

Pharmakon Pharmaceuticals D-0601-2016
Class II · Moderate risk Terminated

Ketamine 100 mg/mL

Reason Stability data does not support expiry.

Pharmakon Pharmaceuticals D-0600-2016