Class II · Moderate risk
Oxycodone Hydrochloride Oral Solution
Impurity failure at 0-time of the repackaged lot.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Alprazolam Tablets
CGMP deviations
Class II · Moderate risk
Dexamethasone Elixir
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Class II · Moderate risk
Moxifloxacin Ophthalmic Solution USP 0.5%
Failed impurities/degradation specifications
Class II · Moderate risk
Olanzapine Tablets
cGmp Deviations
Class II · Moderate risk
Amlodipine and Olmesartan Medoxomil Tablets
cGMP deviations
Class II · Moderate risk
Pyrazinamide Tablets
cGMP Deviations
Class II · Moderate risk
Alprazolam Tablets
cGMP Deviations
Class II · Moderate risk
Alprazolam Tablets
cGMP Deviations
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
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
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
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