Class II · Moderate risk Terminated
Topiramate 25mg Tabs White/round tablets
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Thyroid Neutral Tabs 2 gr
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk Terminated
Thyroid 1 Gr tablets
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk Terminated
Thyroid 1 Grain Tablets
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
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 III · Low risk Terminated
Clobetasol Propionate Cream
Reason Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Class II · Moderate risk Terminated
VILEVEV MB Urinary Antispetic
Reason cGMP deviations
Class II · Moderate risk Terminated
Vilamit Mb
Reason cGMP deviations
Class I · High risk Terminated
Born Basic.
Reason Chemical Contamination: 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
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 I · High risk Terminated
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection
Reason Cross Contamination with other products: trace amounts of lidocaine
Class III · Low risk Terminated
Leucovorin Calcium Tablets USP
Reason Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
Class I · High risk Terminated
Stimate
Reason Superpotent Drug
Class I · High risk Terminated
Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL
Reason Superpotent Drug
Class I · High risk Terminated
DDAVP Nasal Spray
Reason Superpotent Drug
Class II · Moderate risk Terminated
Mibelas 24 Fe
Reason Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Class III · Low risk Terminated
Clobetasol Propionate Cream USP
Reason Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Class II · Moderate risk Terminated
Fentanyl Citrate Inj.
Reason Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Class I · High risk Terminated
OPTIMUS LUBRICANTS Instant Hand Sanitizer
Reason Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Class I · High risk Terminated
OPTIMUS LUBRICANTS Instant Hand Sanitizer
Reason Chemical Contamination: Products contain methanol and were below the label claim for ethanol content