Class II · Moderate risk
Tobramycin Irrigation 80 mg/1000 mL Solution
Lack of Processing Controls
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
Gentamicin
Lack of Processing Controls
Class II · Moderate risk
Dexamethasone Sodium Phosphate PF 24 mg/mL Injection
Lack of Processing Controls
Class II · Moderate risk
Alprostadil 100 mcg/mL Injectable
Lack of Processing Controls
Class II · Moderate risk
Acetylcysteine 2% Otic Drop
Lack of Processing Controls
Class II · Moderate risk
Lisinopril and Hydrochlorothiazide Tablets USP
Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.
Class II · Moderate risk
MONSEL'S (Ferric Subsulfate)
Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content.
Class II · Moderate risk
Atorvastatin Calcium Tablet USP 80 mg
Failed Dissolution Specifications
Class II · Moderate risk
Keppra (levetiracetam)
Failed Dissolution Specifications.
Class III · Low risk
Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of Assurance of Sterility: Bags have potential to leak.
Class II · Moderate risk
Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Class II · Moderate risk
Tamsulosin Hydrochloride Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Lisinopril and Hydrochlorothiazide Tablets USP
Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.
Class II · Moderate risk
Timolol- Dorzolamide- Latanoprost P-F
Subpotent Drug
Class II · Moderate risk
Timolol-Latanoprost P-F
Subpotent Drug
Class III · Low risk
Nystatin and Triamcinolone Acetonide Cream USP100
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
Class II · Moderate risk
Clobazam Oral Suspension
Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
Class II · Moderate risk
Temozolomide Capsules
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk
Temozolomide Capsules
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk
Temozolomide Capsules
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk
Temozolomide Capsules
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk
Temozolomide Capsules
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk
Temozolomide Capsules
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk
CVS Health Children's Nasal Saline Drops with Himalayan Salt Saline Nasal Moisturizer
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.