Class II · Moderate risk
Doxycycline Capsules
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
FDA Drug Recalls
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Class II · Moderate risk
Doxycycline Capsules
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Class II · Moderate risk
Pantoprazole Sodium Delayed-Release Tablets
CGMP Deviations: Presence of dark brown discoloration on edges of tablets
Class II · Moderate risk
Buprenorphine Black Cherry 2 mg Troche
Subpotent Drug
Class II · Moderate risk
Buprenorphine Watermelon 8 mg Troche
Subpotent Drug
Class II · Moderate risk
Buprexone Banana cream 6-0.6 mg Troche
Subpotent Drug
Class II · Moderate risk
Levonorgestrel and Ethinyl Estradiol Tablets USP
Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
Class III · Low risk
Bekyree
Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
Class II · Moderate risk
Sotalol HCL Tablets
Presence of particulate matter. presence of metal particles.
Class II · Moderate risk
Theophylline
CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date.
Class II · Moderate risk
Acetaminophen 500 mg tablet packaged in a) 30-count bottles
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle
Class II · Moderate risk
Epinephrine Injection USP
CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.
Class II · Moderate risk
Sodium Chloride 0.9% Injection
CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
Class III · Low risk
PrediniSONE Tablets
Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
Class II · Moderate risk
Peppermint Lip Moisturizer
Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk
Carbidopa and Levodopa Tablets
Product Mix-Up: A foreign tablet was found in bottle.
Class II · Moderate risk
Sunstar GUM Toothpaste 3 g tubes
cGMP Deviation
Class III · Low risk
Quetiapine Fumarate Extended-Release Tablets
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Class III · Low risk
Quetiapine Fumarate Extended-Release Tablets
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Class III · Low risk
Quetiapine Fumarate Extended-Release Tablets
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.