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.
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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.
Class II · Moderate risk Terminated
Rexall
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk Terminated
Rhinall Nasal Decongestant Nasal Spray
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class I · High risk Terminated
Sinus Relief
Reason Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.
Class II · Moderate risk Terminated
CVS Health
Reason Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
Class II · Moderate risk Terminated
Mushatt's No. 9
Reason Microbial Contamination of Non-Sterile Products and Subpotent Drug: failure for microbiological growth exceeding specification and low out of specification assay results for salicylic acid.
Class II · Moderate risk Terminated
CeraVe Healing Lip Balm/SPF 30
Reason Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.
Class III · Low risk Terminated
Cicatricure
Reason Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.