Class III · Low risk Terminated
Make Up Transparent dark tan
Reason Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
FDA Drug Recalls
1,523 recalls · Class III, newest first
Class III · Low risk Terminated
Make Up Perfect caramel
Reason Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk Terminated
Make Up Transparent sand
Reason Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk Terminated
Make Up Transparent pastel
Reason Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk Terminated
Make Up Transparent ivory
Reason Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk Terminated
Beautipharm Eye Care Balm SPF 10
Reason Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk Terminated
Beautipharm Body Moisturizing Balm SPF 10
Reason Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk Terminated
Beautipharm All Day Moisturizing Balm SPF 10
Reason Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk Terminated
Halyard 24-Hour Oral Care Kit q4
Reason Crystallization with subpotent out of specification assay results for chlorhexidine.
Class III · Low risk Terminated
Halyard 24-Hour Oral Care Kit q2
Reason Crystallization with subpotent out of specification assay results for chlorhexidine.
Class III · Low risk Terminated
Chlorhexidine Gluconate Oral Rinse
Reason Crystallization with subpotent out of specification assay results for chlorhexidine.
Class III · Low risk Terminated
Deferoxamine Mesylate for injection
Reason CGMP Deviations: Firm failed to control impurity for color change at the API stage.
Class III · Low risk Terminated
Pravastatin Sodium Tablets
Reason Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
Class III · Low risk Terminated
Argatroban Injection
Reason Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Class III · Low risk Terminated
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle
Reason Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Class III · Low risk Terminated
Buprenorphine and Naloxone Sublingual Tablets
Reason Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Class III · Low risk Terminated
Obagi-C Rx System C-Therapy Night Cream
Reason Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being recalled due to incomplete packaging/labeling. The bottle is missing the product insert and outer carton which contain the complete instruction for use and safety information.
Class III · Low risk Terminated
Paroxetine Extended-Release Tablets USP
Reason Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
Class III · Low risk Terminated
Amitriptyline HCl Tablets
Reason Cross Contamination With Other Product: Imipramine
Class III · Low risk Terminated
Gaviscon
Reason Superpotent Drug: high out-of-specification result for magnesium.
Class III · Low risk Terminated
Walgreens Daytime and Nighttime Cold & Flu
Reason Labeling: Label Mix-Up - This product is being recalled due to an incorrect product sleeve on the product twin pack. The incorrect product sleeve is for Day-Night Cold and Flu whereas the batch contains Day-Night Cough Liquid.
Class III · Low risk Terminated
G & W Clobetasol Propionate Ointment 0.05%
Reason Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.
Class III · Low risk Terminated
BuPROPion HCL Tablets
Reason Failed Moisture Limits: Product tested out-of-specification for moisture content.
Class III · Low risk Terminated
Ponstel
Reason Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Class III · Low risk Terminated
Mefenamic Acid
Reason Failed Dissolution Specifications: Low dissolution results were obtained during stability testing