Class II · Moderate risk Terminated
TheraTears Extra
Reason Lack of Assurance of Sterility
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Naproxen Sodium Tablets
Reason CGMP Deviations
Class II · Moderate risk Terminated
Naproxen Sodium Tablets
Reason CGMP Deviations
Class II · Moderate risk Terminated
Fulvestrant Injection 250 mg/5 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Betadine Solution Swabstick Povidone-Iodine Solution USP
Reason Subpotent Drug
Class II · Moderate risk Terminated
Rompe Pecho Max Multi-Symptoms Maximum Strength
Reason Microbial Contamination of Non-Sterile Products
Class II · Moderate risk Terminated
Rompe Pecho Ex Expectorant
Reason Microbial Contamination of Non-Sterile Products
Class II · Moderate risk Terminated
Rompe Pecho DM
Reason Microbial Contamination of Non-Sterile Products
Class II · Moderate risk Terminated
Rompe Pecho CF Cold & Flu Advanced Formula
Reason Microbial Contamination of Non-Sterile Products
Class II · Moderate risk Terminated
Lyrica CR
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Betamethasone Dipropionate Lotion USP
Reason 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 Terminated
Aconitum Napellus 12X Fear* 87% Alcohol HPUS: packaged in 30 mL containers
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk Terminated
Aconitum nap Fear* 20% Alcohol HPUS: 6X
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk Terminated
Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 8X
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk Terminated
Aconitum nap Fear* Sucrose/Lactose Pills HPUS: 4X
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk Terminated
Aconitum Napellus Fear* 20% Alcohol HPUS: 5X
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk Terminated
Strophanthus hisp 30X
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk Terminated
Strophanthus hisp 30X
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk Terminated
ZTE 1015 Formula
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk Terminated
ZTE 1013 Formula Antimicrobial - F&M
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.