Class II · Moderate risk
Oxygen
cGMP Deviations; trailer may not have met GMP requirements prior to filling
FDA Drug Recalls
76 recalls, newest first
Class II · Moderate risk
Screenses Color Sunscreen
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Screenses Color Sunscreen Tinted facial make-up compact
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Repaskin 30
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Repaskin 50
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Dryses Aluminum Chlorohydrate Deodorant for Women
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Repaskin 30
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Repaskin 50
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Salises Facial Moisturizing Acne Treatment Gel
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Dryses Aluminum Chlorohydrate Antiperspirant Solution
cGMP Deviations; product does not comply with cGMP requirements
Class III · Low risk
FUROSEMIDE Tablets USP
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Class III · Low risk
FUROSEMIDE Tablets USP
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Class III · Low risk
UN1002 Air
CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
Class III · Low risk
UN1002 Air
CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
Class II · Moderate risk
Lisinopril Tablets USP
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
Class II · Moderate risk
Lisinopril Tablets USP
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
Class II · Moderate risk
Clonidine Hydrochloride Tablets
cGMP Deviations
Class II · Moderate risk
Clonidine Hydrochloride Tablets
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Class II · Moderate risk
Clonidine Hydrochloride Tablets
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Class II · Moderate risk
Clonidine Hydrochloride Tablets
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Class II · Moderate risk
Zonisamide capsules
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Lisinopril tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Lisinopril tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Lisinopril tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.