Class II · Moderate risk
Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Bupivacaine HCl in 0.9% Sodium Chloride in all doses
Lack of sterility assurance.
Class II · Moderate risk
HYDROmorphone HCl in Sodium Chloride 0.9% in all doses
Lack of sterility assurance.
Class II · Moderate risk
Famciclovir Tablets
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 III · Low risk
Simvastatin Tablets
Presence of foreign substance: metallic razor blade was found in one bottle.
Class III · Low risk
Clobetasol Propionate Cream USP
Failed Content Uniformity Specifications
Class II · Moderate risk
DELFLEX Peritoneal Dialysis Solution
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
Class I · High risk
Linezolid Injection 600 mg/300 mL
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Class II · Moderate risk
Dry to Normal Skin Starter Kit
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Class II · Moderate risk
Day Cream SPF15 Cr¿me de jour FPS 15
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Class II · Moderate risk
Divalproex Sodium Delayed Release Tablets USP
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Class III · Low risk
Methylphenidate Hydrochloride Extended-release Tablets
Subpotent Drug
Class III · Low risk
Methylphenidate Hydrochloride Extended-release Tablets
Subpotent Drug
Class II · Moderate risk
Fosphenytoin Sodium Injection
Presence of particulate matter
Class III · Low risk
Gabapentin Oral Solution
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Class II · Moderate risk
0.25% Acetic Acid Irrigation USP
Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
Class II · Moderate risk
SPIRIVA HandiHaler
Failed Stability Specifications
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.