Class II · Moderate risk
Soltice Quick-RUB
CGMP DEVIATIONS
FDA Drug Recalls
1,356 recalls, newest first
Class II · Moderate risk
Unguentine Original Ointment for Burns
CGMP DEVIATIONS
Class II · Moderate risk
Vencedor medicated balm
CGMP DEVIATIONS
Class II · Moderate risk
Alcolado Relampago
CGMP DEVIATIONS
Class II · Moderate risk
Sterile Water for Injection
CGMP Deviations: Potential product carryover.
Class II · Moderate risk
Phenylephrine HCl 20 mg
CGMP DEVIATIONS
Class II · Moderate risk
Phenylephrine HCl 40 mg
CGMP DEVIATIONS
Class II · Moderate risk
Phenylephrine HCl 1mg per 10mL
CGMP DEVIATIONS
Class II · Moderate risk
Phenylephrine HCl 0.5 mg per 5 mL
CGMP DEVIATIONS
Class II · Moderate risk
Testosterone Cypionate Injection
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Class II · Moderate risk
rOPINIRole Tablets USP 5 mg* 100-count bottle
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
rOPINIRole Tablets USP 4 mg* 100-count bottle
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
rOPINIRole Tablets USP 3 mg*
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
rOPINIRole Tablets USP 2 mg*
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
rOPINIRole Tablets USP 1 mg*
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
rOPINIRole Tablets USP 0.5 mg*
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
rOPINIRole Tablets USP 0.25 mg*
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Pravastatin Sodium Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Pravastatin Sodium Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Pravastatin Sodium Tablets USP 20 mg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Pravastatin Sodium Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Pirfenidone Tablets 801 mg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Pirfenidone Tablets 267 mg 90-count bottle x3/Carton
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Vigabatrin for Oral Solution
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations: recalling drug products following an FDA inspection.