Class II · Moderate risk
SPIRIVA HandiHaler
Failed Stability Specifications
FDA Drug Recalls
893 recalls · Class II, newest first
Class II · Moderate risk
Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class II · Moderate risk
Shiseido Future Solution LX Luxurious Eye & Lip Collection contains SPF 50+
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class II · Moderate risk
Shiseido Future Solution LX Discovery Set contains SPF 50+
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class II · Moderate risk
Shiseido Future Solution LX Universal Defense SPF 50+
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class II · Moderate risk
bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class II · Moderate risk
Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP
Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.
Class II · Moderate risk
INFeD (Iron Dextran Injection USP)
Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
Class II · Moderate risk
Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant
Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia
Class II · Moderate risk
Neutrogena Elevated 4-Holiday Trays
Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Class II · Moderate risk
Neutrogena deep clean purifying whipped foam cleanser
Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Class II · Moderate risk
Neutrogena Acne Proofing whipped foam cleanser
Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Class II · Moderate risk
Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe
Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date.
Class II · Moderate risk
Gabapentin Tablets
Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg
Class II · Moderate risk
Viokace (pancrelipase)
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
All sterile drug preparations remaining within expiry prepared…
Lack of sterility assurance.
Class II · Moderate risk
All sterile drug preparations remaining within expiry prepared…
Lack of sterility assurance.
Class II · Moderate risk
All sterile drug preparations remaining within expiry prepared…
Lack of sterility assurance.
Class II · Moderate risk
All sterile drug preparations remaining within expiry prepared…
Lack of sterility assurance.
Class II · Moderate risk
Valsartan Tablets
Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
Class II · Moderate risk
Vertra Elemental Resistance
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
Glenmark Mometasone Furoate Cream
CGMP Deviations: Market complaints related to "gritty texture".
Class II · Moderate risk
Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg)
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
Paroxetine Tablets USP
Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Class II · Moderate risk
Pravastatin Sodium USP
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.