Class II · Moderate risk Terminated
Thyroid 1 Grain Tablets
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Hydrochlorothiazide 50mg tablets
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk Terminated
Hydrochlorothiazide
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk Terminated
Hydrochlorothiazide 25mg tablets
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk Terminated
VILEVEV MB Urinary Antispetic
Reason cGMP deviations
Class II · Moderate risk Terminated
Vilamit Mb
Reason cGMP deviations
Class II · Moderate risk Terminated
LUX EOI Hand Sanitizing Gel
Reason CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk Terminated
Born Basic.
Reason CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk Terminated
scent theory KEEP CLEAN Moisturizing Hand Sanitizer
Reason CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk Terminated
scent theory KEEP IT CLEAN
Reason CGMP Deviations: Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk Terminated
Mibelas 24 Fe
Reason Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Class II · Moderate risk Terminated
Fentanyl Citrate Inj.
Reason Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Class II · Moderate risk Terminated
Lisinopril Tablets USP
Reason Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg
Class II · Moderate risk Terminated
HGH Vitality Homeopathic
Reason Labeling: Error on Declared Strength
Class II · Moderate risk Terminated
Bersih Hand Sanitizer Gel
Reason cGMP Deviations
Class II · Moderate risk Terminated
Lidocaine Patch 5%
Reason Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
Class II · Moderate risk Terminated
Hydrocortisone butyrate Cream
Reason SUBPOTENT DRUG
Class II · Moderate risk Terminated
Modesa instant HAND SANITIZER with moisturizers & vitamin E
Reason CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
Class II · Moderate risk Terminated
ASSURED Instant Hand Sanitizer Aloe & Moisturizers
Reason CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
Class II · Moderate risk Terminated
ASSURED Instant Hand Sanitizer Vitamin E and Aloe
Reason CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
Class II · Moderate risk Terminated
blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT
Reason CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
Class II · Moderate risk Terminated
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL
Reason CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
Class II · Moderate risk Terminated
blumen ADVANCED HAND SANITIZER
Reason CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
Class II · Moderate risk Terminated
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70%…
Reason CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Auryxia
Reason cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.