Class II · Moderate risk
Hydrocortisone Ointment
Failed Stability Specifications
FDA Drug Recalls
1,590 recalls, newest first
Class II · Moderate risk
Minivelle (estradiol transdermal system)
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
Minivelle (estradiol transdermal system)
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
Zoma Shampoo
Subpotent
Class III · Low risk
T Shampoo For Hair and Body
Subpotent
Class II · Moderate risk
MD Complete Clarifying Cleanser
GMP Deviations
Class II · Moderate risk
Naturmetic SPF 50 Sunscreen
GMP Deviations
Class II · Moderate risk
Solar Defense Sheer Sunscreen Broad Spectrum SPF50
GMP Deviations
Class II · Moderate risk
B Prox 10 Anti-blemish Wash
Microbial Contamination of Non-sterile Product
Class I · High risk
Piperacillin and Tazobactam for Injection
Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
Class I · High risk
Ampicillin and Sulbactam for Injection
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
Loxapine Capsules
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
Loxapine Capsules
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
Lidocaine Patch 5%
Failed Stability Specifications
Class II · Moderate risk
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Docetaxel injection concentrate
Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
Class III · Low risk
Riomet (metformin hydrochloride oral solution)
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
Macroaggregated albumin
Lack of Assurance of Sterility
Class II · Moderate risk
Loxapine Capsules
CGMP Deviations
Class II · Moderate risk
Loxapine Capsules
CGMP Deviations
Class II · Moderate risk
Amlodipine and Benazapril HCL Capsules
cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
Class II · Moderate risk
Amlodipine and Benazapril HCL Capsules
cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
Class II · Moderate risk
Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets
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).