Class II · Moderate risk
Glutathione 200 mg/mL Injectable
Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial.
FDA Drug Recalls
20 recalls, newest first
Class III · Low risk
Eye Drops Advanced Relief
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class III · Low risk
Eye Drops Industrial Strength
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class III · Low risk
Eye Drops A.C.
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class III · Low risk
Eye Drops (Tetrahydrozoline HCl 0.05%)
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class III · Low risk
Z-Cote Hp 1 Transparent Zinc Oxide
cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1.
Class II · Moderate risk
Cephalexin Monohydrate Capsules
CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.
Class II · Moderate risk
Propranolol Hydrochloride Injection
CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.
Class II · Moderate risk
Tetrahydrozoline Hydrochloride
CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class II · Moderate risk
Tetrahydrozoline HCL
CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class II · Moderate risk
Clonidine HCL
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
Class II · Moderate risk
Clonidine Base Micronized
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
Class II · Moderate risk
Propranolol HCl
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
Class II · Moderate risk
Dipyridamole API
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
Class II · Moderate risk
Cephalexin Capsules
CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
Class II · Moderate risk
Cephalexin Capsules
CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
Class II · Moderate risk
METHYLDOPA Tablets USP
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Class II · Moderate risk
INDOMETHACIN Capsules USP
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.
Class II · Moderate risk
INDOMETHACIN Capsules USP
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Class II · Moderate risk
GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements