Class I · High risk
X-ROCK 3 Day Pill For Men
Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
FDA Drug Recalls
530 recalls, newest first
Class II · Moderate risk
CosMedix Serious Protection
Microbial Contamination of Non Sterile Product; mold
Class II · Moderate risk
Daytrana (methylphenidate)
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Class II · Moderate risk
Daytrana (methylphenidate)
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Class II · Moderate risk
Daytrana (methylphenidate)
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Class III · Low risk
Major brand Infants' Mapap
Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should correctly state 4/2014
Class II · Moderate risk
Fentanyl Transdermal System
Subpotent; some patches may not contain fentanyl gel
Class II · Moderate risk
Levothroid
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Thyro-Tab 0.300 mg.
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Levothroid
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Thyro-Tab 0.137 mg.
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Levothroid
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Thyro-Tab 0.125 mg.
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Levothroid
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Thyro-Tab 0.112 mg.
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Levothroid
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Thyro-Tab 0.088 mg.
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Levothroid
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Thyro-Tab 0.050 mg.
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Naproxen Tablets USP
Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.
Class III · Low risk
Hydroxyzine Hydrochloride Oral Solution
Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
Class III · Low risk
HYDROCORTISONE and ACETIC ACID OTIC SOLUTION
Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
Class II · Moderate risk
Leucovorin Calcium Injection USP
Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample.
Class III · Low risk
Carboplatin Injection
Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.
Class III · Low risk
Nexium (esomeprazole magnesium)
Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules.