Class II · Moderate risk Terminated
PROBLEND Hand Sanitizer
Reason CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
7 Eleven Hand Sanitizer Gel
Reason CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II · Moderate risk Terminated
7 Eleven FOR GAS ISLAND USE ONLY
Reason CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II · Moderate risk Terminated
PROBLEND E3 Foaming Hand Sanitizer
Reason CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II · Moderate risk Terminated
PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser
Reason CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II · Moderate risk Ongoing
Broncochem Cold & Tea
Reason Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Class II · Moderate risk Ongoing
Broncochem Cold & Flu Syrup Kids
Reason Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Class II · Moderate risk Ongoing
Fluticasone Propionate Nasal Spray USP
Reason CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Class II · Moderate risk Terminated
Oseltamivir Phosphate for Oral Suspension 6mg/ml
Reason Failed Impurities/Degradation Specifications: Out-of-specification test results.
Class II · Moderate risk Ongoing
Clobazam Tablets 10mg
Reason CGMP Deviations: Out of specification for residual solvents.
Class II · Moderate risk Terminated
Cabtreo
Reason CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
Class II · Moderate risk Terminated
Telmisartan Tablets
Reason Failed Stability Specifications: Out of specification for blend uniformity.
Class II · Moderate risk Ongoing
Fluticasone Propionate Nasal Spray USP 50mcg
Reason CGMP Deviations: potential presence of Burkholderia cepacia complex
Class II · Moderate risk Terminated
HydrALAZINE Hydrochloride Tablets
Reason an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
Class II · Moderate risk Terminated
Bicillin L-A
Reason cGMP Deviations: Products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Infuvite Adult Multiple vitamins injection
Reason cGMP Deviations: Products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Rocuronium Bromide Injection
Reason cGMP Deviations: Products were stored outside the drug label specifications.
Class II · Moderate risk Ongoing
Terlivaz
Reason cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Class II · Moderate risk Ongoing
Acthar Gel
Reason cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Class II · Moderate risk Ongoing
Mesalamine Extended-Release Capsules
Reason Failed Dissolution Specifications: Out of specification for dissolution.
Class II · Moderate risk Terminated
Voriconazole for Oral Suspension
Reason Labeling: Incorrect or Missing Package Insert
Class II · Moderate risk Completed
Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1
Reason Subpotent Drug: Out of specification for assay
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Capsules USP
Reason CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
Class II · Moderate risk Ongoing
Lubricant PM Ointment
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
CVS Health Lubricant Eye Ointment
Reason Lack of Assurance of Sterility