Class II · Moderate risk Terminated
Divalproex Sodium Delayed Release Tablets
Reason Failed Dissolution Specifications; 9 month long term stability
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Testosterone Cypionate Injection
Reason Presence of Particulate Matter
Class II · Moderate risk Terminated
Sulfamethoxazole and Trimethoprim Oral Suspension
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Cotellic
Reason Superpotent Drug: An oversized tablet was found in a bottle.
Class II · Moderate risk Terminated
Metronidazole Injection
Reason Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Class II · Moderate risk Terminated
Levofloxacin Injection in 5% Dextrose
Reason Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Class II · Moderate risk Terminated
Fluconazole Injection
Reason Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Class II · Moderate risk Terminated
Ciprofloxacin in Dextrose
Reason Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Class II · Moderate risk Terminated
hydrALAZINE HYDROCHLORIDE INJECTION
Reason Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.
Class II · Moderate risk Terminated
Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection
Reason CGMP Deviations
Class II · Moderate risk Terminated
ATENOLOL Tablets
Reason Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
Class II · Moderate risk Terminated
Tiger King tablets
Reason Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Class II · Moderate risk Terminated
MAX MAN capsules
Reason Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Class II · Moderate risk Terminated
STREE OVERLORD capsules
Reason Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Class II · Moderate risk Terminated
Ye Lang Shen capsules
Reason Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Class II · Moderate risk Terminated
HARD TEN DAYS capsules
Reason Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Class II · Moderate risk Terminated
Black Ant capsules
Reason Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Class II · Moderate risk Terminated
Sensodyne Repair & Protect Whitening
Reason Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent
Class II · Moderate risk Terminated
ATENOLOL Tablets
Reason Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
Class II · Moderate risk Terminated
Desonide Ointment
Reason Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream
Class II · Moderate risk Ongoing
Double Hyaluronic 1000
Reason Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial contamination.
Class II · Moderate risk Completed
Aspirin Chewable Tablets
Reason Presence of Foreign Substance: foreign material found in the bulk inventory.
Class II · Moderate risk Terminated
Fentanyl Citrate and Bupivacaine HCl all strengths
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk Terminated
Fentanyl Citrate with Ropivacaine HCl all strengths
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk Terminated
Sodium Citrate all strengths
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.