Class II · Moderate risk Terminated
Acetaminophen Child Dye Free Cherry Flavor Oral Suspension
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
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Class II · Moderate risk Terminated
Infant's Grape Flavored Acetaminophen Oral Suspension
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk Terminated
Acetaminophen Infant Dye Free Grape Oral Suspension
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk Terminated
Acetaminophen Child Strawberry Oral Suspension
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk Terminated
Children's Cherry Flavored Acetaminophen Oral Suspension
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk Terminated
Children's Grape Flavored Acetaminophen Oral Suspension
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk Terminated
Children's Pain & Fever Bubblegum Flavored Acetaminophen Suspension
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk Terminated
Acetaminophen Oral Suspension Grape Flavor
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class III · Low risk Terminated
Topiramate Tablets
Reason Discoloration
Class II · Moderate risk Terminated
Tadalafil Tablets
Reason Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Class II · Moderate risk Terminated
Tadalafil Tablets
Reason Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Class II · Moderate risk Terminated
Pregabalin Capsules
Reason Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Class III · Low risk Terminated
Gatifloxacin Ophthalmic Solution
Reason Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Class II · Moderate risk Terminated
Diclofenac Sodium Topical Solution USP
Reason Defective Container
Class II · Moderate risk Terminated
Diclofenac Sodium Topical Solution USP
Reason Defective Container
Class I · High risk Terminated
Cubicin
Reason Presence of Particulate Matter: Identified as Glass Particles
Class III · Low risk Terminated
Rizatriptan Benzoate Orally Disintegrating Tablets 10mg
Reason Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Class III · Low risk Terminated
Rizatriptan Benzoate Orally Disintegrating Tablets 5mg
Reason Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Class III · Low risk Terminated
Rizatriptan Benzoate Film Coated Tablets
Reason Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Class II · Moderate risk Terminated
Ezetimibe and Simvastatin Tablets
Reason Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk Terminated
Ezetimibe and Simvastatin Tablets
Reason Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Class III · Low risk Terminated
Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk Terminated
Xpect First aid Extra Strength PAIN AWAY
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk Terminated
Advance Formula Pain Reliever
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk Terminated
North by Honeywell PAIN STOPPER EXTRA STRENGTH
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.