Class III · Low risk Terminated
Simvastatin Tablets
Reason Presence of foreign substance: metallic razor blade was found in one bottle.
FDA Drug Recalls
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Class III · Low risk Terminated
Clobetasol Propionate Cream USP
Reason Failed Content Uniformity Specifications
Class II · Moderate risk Terminated
DELFLEX Peritoneal Dialysis Solution
Reason Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
Class I · High risk Terminated
Linezolid Injection 600 mg/300 mL
Reason Presence of Particulate Matter; white particulate matter identified as mold was found in one 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 III · Low risk Terminated
Methylphenidate Hydrochloride Extended-release Tablets
Reason Subpotent Drug
Class III · Low risk Terminated
Methylphenidate Hydrochloride Extended-release Tablets
Reason Subpotent Drug
Class II · Moderate risk Terminated
Fosphenytoin Sodium Injection
Reason Presence of particulate matter
Class III · Low risk Terminated
Gabapentin Oral Solution
Reason CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
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 III · Low risk Terminated
Auryxia
Reason Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.
Class I · High risk Terminated
BodySlim Herbal Advanced technology & Strong formula capsules
Reason Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine.
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.