Class II · Moderate risk Terminated
Preferred Plus Pharmacy Antacid
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Preferred Plus Pharmacy Antacid Extra Strength
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk Terminated
Hydrocortisone Ointment
Reason Failed Stability Specifications
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 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 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 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 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).
Class II · Moderate risk Terminated
Clindamycin 300 mg capsules
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).
Class II · Moderate risk Terminated
Chlorhexidine 0.12% liquid
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).
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).
Class II · Moderate risk Terminated
Clindamycin 150 mg capsules
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).