Class II · Moderate risk Terminated
Hydrocortisone Ointment
Reason Failed Stability Specifications
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Minivelle
Reason Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
Class II · Moderate risk Terminated
Minivelle
Reason Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
Class III · Low risk Terminated
Zoma Shampoo
Reason Subpotent
Class III · Low risk Terminated
T Shampoo For Hair and Body
Reason Subpotent
Class II · Moderate risk Terminated
MD Complete Clarifying Cleanser
Reason GMP Deviations
Class II · Moderate risk Terminated
Naturmetic SPF 50 Sunscreen
Reason GMP Deviations
Class II · Moderate risk Terminated
Solar Defense Sheer Sunscreen Broad Spectrum SPF50
Reason GMP Deviations
Class II · Moderate risk Terminated
B Prox 10 Anti-blemish Wash
Reason Microbial Contamination of Non-sterile Product
Class I · High risk Terminated
Piperacillin and Tazobactam for Injection
Reason Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
Class I · High risk Terminated
Ampicillin and Sulbactam for Injection
Reason Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.
Class II · Moderate risk Terminated
Loxapine Capsules
Reason GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Class II · Moderate risk Terminated
Loxapine Capsules
Reason GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Class III · Low risk Terminated
Lidocaine Patch 5%
Reason Failed Stability Specifications
Class II · Moderate risk Terminated
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets
Reason CGMP Deviations
Class II · Moderate risk Terminated
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg
Reason CGMP Deviations
Class II · Moderate risk Terminated
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg
Reason CGMP Deviations
Class II · Moderate risk Terminated
Docetaxel injection concentrate
Reason Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
Class III · Low risk Terminated
Riomet
Reason Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
Class II · Moderate risk Terminated
Macroaggregated albumin
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Loxapine Capsules
Reason CGMP Deviations
Class II · Moderate risk Terminated
Loxapine Capsules
Reason CGMP Deviations
Class II · Moderate risk Terminated
Amlodipine and Benazapril HCL Capsules
Reason cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
Class II · Moderate risk Terminated
Amlodipine and Benazapril HCL Capsules
Reason cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
Class II · Moderate risk Terminated
Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets
Reason Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).