Class III · Low risk
Albuterol Sulfate Inhalation Solution
Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
FDA Drug Recalls
165 recalls · Class III, newest first
Class III · Low risk
Voriconazole Tablets
Failed impurities/degradation specifications: Out of specification for a related compound C.
Class III · Low risk
Make Up Perfect terra
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk
Make Up Perfect dark tan
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk
Make Up Perfect sand
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk
Make Up Perfect pastel
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk
Make Up Perfect ivory
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk
Make Up Transparent terra
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk
Make Up Transparent dark tan
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk
Make Up Perfect caramel
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk
Make Up Transparent sand
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk
Make Up Transparent pastel
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk
Make Up Transparent ivory
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk
Beautipharm Eye Care Balm SPF 10
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk
Beautipharm Body Moisturizing Balm SPF 10
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk
Beautipharm All Day Moisturizing Balm SPF 10
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk
Halyard 24-Hour Oral Care Kit q4
Crystallization with subpotent out of specification assay results for chlorhexidine.
Class III · Low risk
Halyard 24-Hour Oral Care Kit q2
Crystallization with subpotent out of specification assay results for chlorhexidine.
Class III · Low risk
Chlorhexidine Gluconate Oral Rinse
Crystallization with subpotent out of specification assay results for chlorhexidine.
Class III · Low risk
Deferoxamine Mesylate for injection
CGMP Deviations: Firm failed to control impurity for color change at the API stage.
Class III · Low risk
Pravastatin Sodium Tablets
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
Class III · Low risk
Argatroban Injection
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Class III · Low risk
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Class III · Low risk
Buprenorphine and Naloxone Sublingual Tablets
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Class III · Low risk
Obagi-C Rx System C-Therapy Night Cream
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.