Class II · Moderate risk
Alprazolam Tablets
cGMP Deviations
FDA Drug Recalls
1,206 recalls · Class II, newest first
Class II · Moderate risk
Alprazolam Tablets
cGMP Deviations
Class II · Moderate risk
Alprazolam Tablets
cGMP Deviations
Class II · Moderate risk
Diazepam Oral Solution
Failed Impurities/Degradation Specifications: Out of specification results for related substances.
Class II · Moderate risk
Erythromycin Topical Gel USP
Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
Class II · Moderate risk
Luxury 70% Isopropyl Alcohol
Labeling - product contains undeclared ethyl alcohol
Class II · Moderate risk
70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen
Labeling - product contains undeclared ethyl alcohol
Class II · Moderate risk
Chlorthalidone Tablets USP 25 mg
Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
Class II · Moderate risk
Methylphenidate Hydrochloride Chewable Tablets
Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.
Class II · Moderate risk
Prevantics
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Class II · Moderate risk
Prevantics
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Class II · Moderate risk
Prevantics
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Class II · Moderate risk
Premium Nature Instant Hand Sanitizer
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Class II · Moderate risk
Premium Nature Instant Hand Sanitizer
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Class II · Moderate risk
Cystex Tablet
CGMP Deviations
Class II · Moderate risk
DBI Magnums Tablet
CGMP Deviations
Class II · Moderate risk
Coated Back Relief Tablet
CGMP Deviations
Class II · Moderate risk
Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg)
CGMP Deviations
Class II · Moderate risk
Back Relief II
CGMP Deviations
Class II · Moderate risk
Pain Aid PMF Caplet
CGMP Deviations
Class II · Moderate risk
Normed Fem Tablet
CGMP Deviations
Class II · Moderate risk
APAP 325 mg
CGMP Deviations
Class II · Moderate risk
Migrenol Caplet
CGMP Deviations
Class II · Moderate risk
Coated Phenylephrine HCl 5mg Tablet
CGMP Deviations
Class II · Moderate risk
Phenylephrine HCl 5 mg Tablet
CGMP Deviations