Class II · Moderate risk Terminated
INFeD
Reason Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant
Reason Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia
Class II · Moderate risk Terminated
Neutrogena Elevated 4-Holiday Trays
Reason Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Class II · Moderate risk Terminated
Neutrogena deep clean purifying whipped foam cleanser
Reason Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Class II · Moderate risk Terminated
Neutrogena Acne Proofing whipped foam cleanser
Reason Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Class II · Moderate risk Terminated
Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe
Reason Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date.
Class II · Moderate risk Terminated
Gabapentin Tablets
Reason Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg
Class II · Moderate risk Terminated
Viokace
Reason Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.
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
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.