Class II · Moderate risk Terminated
Cyclosporine 1% Human Eye Drops
Reason Lack of Process Controls
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
ADAA Cataract Drops
Reason Lack of Process Controls
Class II · Moderate risk Terminated
Alprostadil 500 mcg/mL Injectable
Reason Incorrect Product Formulation
Class III · Low risk Terminated
Contrave
Reason Defective Container: Customer complaints of punctures in the bottle.
Class III · Low risk Terminated
Azelastine HCl Ophthalmic Solution 0.05%
Reason Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Class III · Low risk Terminated
Diltiazem HCl Extended-Release Capsules
Reason Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Class III · Low risk Terminated
Diltiazem HCl Extended-Release Capsules
Reason Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Class II · Moderate risk Terminated
Doxycycline Hyclate USP Tablets
Reason Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.
Class II · Moderate risk Terminated
PIO&METFORMIN 15/1000 mg Tab 1
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended Release Tablets 1000 mg
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended Release Tablets 1000 mg
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended Release Tablets
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk Terminated
Fortamet
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk Terminated
Paliperidone Extended Release Tablets 9 mg
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk Terminated
Paliperidone Extended Release Tablets 3 mg
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class I · High risk Terminated
Levothyroxine and Liothyronine
Reason Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Class I · High risk Terminated
Levothyroxine and Liothyronine
Reason Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Class I · High risk Terminated
Levothyroxine and Liothyronine
Reason Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Class I · High risk Terminated
Levothyroxine and Liothyronine
Reason Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Class I · High risk Terminated
Levothyroxine and Liothyronine
Reason Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Class III · Low risk Terminated
Acne Treatment Pads
Reason Subpotent drug: The product active ingredient level not matching the exact levels indicated on the packaging label.
Class II · Moderate risk Terminated
Family Dollar Saline Nasal Spray 4.25 oz. can
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk Terminated
Finafta Baby
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk Terminated
Rexall
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk Terminated
Rexall
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.