Class II · Moderate risk Ongoing
Nicardipine Hydrochloride Injection
Reason Failed Impurities/Degradation Specifications: Out of specification for organic impurities
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Class II · Moderate risk Ongoing
Methylprednisolone acetate Injectable Suspension
Reason Failed Dissolution Specifications
Class III · Low risk Ongoing
Clindamycin Phosphate Topical Solution USP
Reason Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Class III · Low risk Ongoing
Clindamycin Phosphate
Reason Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Class II · Moderate risk Ongoing
Lidocaine HCL 1%
Reason Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II · Moderate risk Ongoing
Moxifloxacin 5mg/ml
Reason Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II · Moderate risk Ongoing
Moxifloxacin PF
Reason Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II · Moderate risk Terminated
PROBLEND Hand Sanitizer
Reason CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
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 I · High risk Ongoing
Methocarbamol Injection
Reason Presence of Particulate Matter
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 I · High risk Terminated
ForeverMen Natural Energy Boost Capsules
Reason Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.
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 III · Low risk Terminated
Mercaptopurine Tablets
Reason Failed Dissolution Specifications: results slightly under spec at at 9-months.
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.