Class II · Moderate risk
TheraTears Extra
Lack of Assurance of Sterility
FDA Drug Recalls
921 recalls · Class II, newest first
Class II · Moderate risk
Valproic Acid Oral Solution USP
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Promethazine With Codeine Oral Solution
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Promethazine Syrup Plain
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Meclizine HCl Tablets
Labeling: Incorrect Instructions
Class II · Moderate risk
Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral…
Lack of Assurance of Sterility
Class II · Moderate risk
Class II · Moderate risk
Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC…
CGMP Deviations
Class II · Moderate risk
Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC…
CGMP Deviations
Class II · Moderate risk
Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC…
CGMP Deviations
Class II · Moderate risk
Naproxen Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Naproxen Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Fulvestrant Injection 250 mg/5 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Betadine Solution Swabstick Povidone-Iodine Solution USP
Subpotent Drug
Class II · Moderate risk
Rompe Pecho Max Multi-Symptoms Maximum Strength
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Rompe Pecho Ex Expectorant
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Rompe Pecho DM
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Rompe Pecho CF Cold & Flu Advanced Formula
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Lyrica CR (pregabalin)
Failed Dissolution Specifications
Class II · Moderate risk
Betamethasone Dipropionate Lotion USP
Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing
Class II · Moderate risk
Aconitum Napellus 12X Fear* 87% Alcohol HPUS: packaged in 30 mL containers
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Aconitum nap Fear* 20% Alcohol HPUS: 6X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 8X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Aconitum nap Fear* Sucrose/Lactose Pills HPUS: 4X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Aconitum Napellus Fear* 20% Alcohol HPUS: 5X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.