Class II · Moderate risk Ongoing
Med Pride
Reason CGMP Deviations; deficiencies observed during FDA inspection
FDA Drug Recalls
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Class II · Moderate risk Ongoing
Med Pride
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Med Pride
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Med Pride
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Med Pride
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Med Pride
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Med Pride
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Med Pride
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Cura Hongos
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Rapidol
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Lil Drug Store
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Circle K
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Lucky Super Soft
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Lucky Super Soft
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class III · Low risk Ongoing
hydrOXYzine Hydrochloride Oral Solution
Reason Presence of foreign substance
Class II · Moderate risk Ongoing
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag
Reason Incorrect product formulation: bag did not contain copper and famotidine per label.
Class III · Low risk Ongoing
Fexofenadine Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications
Class I · High risk Ongoing
BEEKEEPER'S NATURALS Saline Nasal Spray
Reason Microbial Contamination of Non-Sterile Products
Class III · Low risk Ongoing
Focalin XR
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class II · Moderate risk Ongoing
Minocycline Hydrochloride Extended-Release Tablets
Reason Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Class II · Moderate risk Ongoing
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%
Reason Subpotent drug
Class II · Moderate risk Ongoing
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%
Reason Subpotent drug
Class II · Moderate risk Ongoing
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%
Reason Subpotent drug
Class II · Moderate risk Ongoing
Gasco Isopropyl Alcohol 70%
Reason Subpotent drug
Class II · Moderate risk Ongoing
Gasco Isopropyl Alcohol 70%
Reason Subpotent drug