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.
FDA Drug Recalls
11,818 recalls · Class II, newest first
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 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.
Class II · Moderate risk
DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
CVS Health Children's Allergy Relief Liquid Medication…
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
LA FRESH travel lite Sunnyside Lotion Wipe silky
Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling of the product and comments about the product found on e-commerce websites.
Class II · Moderate risk
Fungo Off Capsules
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk
Asma Stopper Capsules
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk
Anemia Off
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk
Appetrol Capsules
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk
Mental Tonic Capsules
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk
Thyro-Lo
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk
Smoke End Capsules
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk
Detensin
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk
Yeast Douche Powder
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.