US Drug Recall Register

FDA Drug Recalls

14,450 recalls · Class II, newest first

Class II · Moderate risk Terminated

Human Chorionic Gonadotropin 5

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

KRS Global Biotechnology, Inc D-0175-2018
Class II · Moderate risk Terminated

Human Chorionic Gonadotropin 2

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

KRS Global Biotechnology, Inc D-0174-2018
Class II · Moderate risk Terminated

Estriol 0.1%

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

KRS Global Biotechnology, Inc D-0172-2018
Class II · Moderate risk Terminated

Bi-Est

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

KRS Global Biotechnology, Inc D-0168-2018
Class II · Moderate risk Terminated

Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream packaged in jars

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

KRS Global Biotechnology, Inc D-0167-2018
Class II · Moderate risk Terminated

Benzocaine 20%

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

KRS Global Biotechnology, Inc D-0166-2018
Class II · Moderate risk Terminated

Benzocaine 20%

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

KRS Global Biotechnology, Inc D-0165-2018
Class II · Moderate risk Terminated

Anastrozole SR 1 mg Capsules

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

KRS Global Biotechnology, Inc D-0163-2018
Class II · Moderate risk Terminated

Anastrozole 0.5 mg Capsules

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

KRS Global Biotechnology, Inc D-0161-2018
Class II · Moderate risk Terminated

0.9% Sodium Chloride Injection

Reason Lack of Assurance of Sterility

Fresenius Medical Care Renal Therapies Group, LLC NDC 49230-0300-10 D-0827-2018
Class II · Moderate risk Terminated

Liothyronine Sodium Tablets

Reason Failed Dissolution Specifications.

Mayne Pharma Inc NDC 0574-0222-01 D-0098-2018
Class II · Moderate risk Terminated

Clozapine Tablets USP

Reason Failed Tablet/Capsule Specifications; potential presence of broken tablets.

Teva Pharmaceuticals USA NDC 00093-7772-05 D-0096-2018
Class II · Moderate risk Terminated

Maximum Strength Zephrex-D

Reason Microbial Contamination of Non-Sterile Products

L. Perrigo Company NDC 70085-151-01 D-0128-2018
Class II · Moderate risk Terminated

Extra Strength PreTAT by TAT BALM Gel

Reason GMP Deviations: inadequate manufacturing control processes

Ridge Properties, LLC NDC 69804-018-09 D-0087-2018