Class II · Moderate risk Terminated
All sterile drug preparations remaining within expiry prepared…
Reason Lack of sterility assurance.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
All sterile drug preparations remaining within expiry prepared…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
All sterile drug preparations remaining within expiry prepared…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Valsartan Tablets
Reason Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
Class II · Moderate risk Terminated
Vertra Elemental Resistance
Reason CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.
Class II · Moderate risk Terminated
Glenmark Mometasone Furoate Cream
Reason CGMP Deviations: Market complaints related to "gritty texture".
Class II · Moderate risk Terminated
Amethyst
Reason Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
Class II · Moderate risk Terminated
Paroxetine Tablets USP
Reason Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Class II · Moderate risk Terminated
Pravastatin Sodium USP
Reason Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle.
Class II · Moderate risk Terminated
7-Keto DHEA 25mg Capsule
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.
Class II · Moderate risk Terminated
7-Ketodehydroepiandrosterone
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.
Class II · Moderate risk Terminated
Vitamin 10 B Lyophilized Vial
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.
Class II · Moderate risk Terminated
Vitamin 9 A/B Lyophilized Vial
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.
Class II · Moderate risk Terminated
Vitamin 9 Lyophilized Vial
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.
Class II · Moderate risk Terminated
Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 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.
Class II · Moderate risk Terminated
Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 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.
Class II · Moderate risk Terminated
T-105
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.
Class II · Moderate risk Terminated
Trimix #23F
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.
Class II · Moderate risk Terminated
Trimix #22F
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.
Class II · Moderate risk Terminated
Sincalide 5 mcg Lyophilized Vials
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.
Class II · Moderate risk Terminated
Sermorelin Acetate 3 mg/ GHRP6 3 mg
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.
Class II · Moderate risk Terminated
Sermorelin
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.
Class II · Moderate risk Terminated
Sermorelin
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.
Class II · Moderate risk Terminated
Sermorelin 500 mcg Orally Disintegrating Tablets
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.
Class II · Moderate risk Terminated
Savinase 100 mcg/mL Topical Solution
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.