Class II · Moderate risk Terminated
Midazolam HCl in 5% Dextrose in all strengths
Reason Lack of sterility assurance.
FDA Drug Recalls
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Class II · Moderate risk Terminated
Midazolam HCl in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
HYDROmorphone HCl Injection in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Ephedrine Sulfate in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Bupivacaine HCl in 0.9% Sodium Chloride in all doses
Reason Lack of sterility assurance.
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 III · Low risk Terminated
Simvastatin Tablets
Reason Presence of foreign substance: metallic razor blade was found in one bottle.
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.