Class II · Moderate risk Terminated
Bupivacaine HCl in 0.9% Sodium Chloride in all doses
Reason Lack of sterility assurance.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
HYDROmorphone HCl in Sodium Chloride 0.9% in all doses
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Famciclovir Tablets
Reason Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.
Class II · Moderate risk Terminated
DELFLEX Peritoneal Dialysis Solution
Reason Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
Class II · Moderate risk Terminated
Dry to Normal Skin Starter Kit
Reason Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Class II · Moderate risk Terminated
Day Cream SPF15 Cr¿me de jour FPS 15
Reason Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Class II · Moderate risk Terminated
Divalproex Sodium Delayed Release Tablets USP
Reason Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Class II · Moderate risk Terminated
Fosphenytoin Sodium Injection
Reason Presence of particulate matter
Class II · Moderate risk Terminated
0.25% Acetic Acid Irrigation USP
Reason Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
Class II · Moderate risk Terminated
SPIRIVA HandiHaler
Reason Failed Stability Specifications
Class II · Moderate risk Terminated
Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+
Reason GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class II · Moderate risk Terminated
Shiseido Future Solution LX Luxurious Eye & Lip Collection contains SPF 50+
Reason GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class II · Moderate risk Terminated
Shiseido Future Solution LX Discovery Set contains SPF 50+
Reason GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class II · Moderate risk Terminated
Shiseido Future Solution LX Universal Defense SPF 50+
Reason GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class II · Moderate risk Terminated
bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion
Reason GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class II · Moderate risk Terminated
Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP
Reason 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 Terminated
INFeD
Reason Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
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.