Class II · Moderate risk Terminated
Tamsulosin Hydrochloride Capsules
Reason Failed Dissolution Specifications
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Lisinopril and Hydrochlorothiazide Tablets USP
Reason 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 Terminated
Timolol- Dorzolamide- Latanoprost P-F
Reason Subpotent Drug
Class II · Moderate risk Terminated
Timolol-Latanoprost P-F
Reason Subpotent Drug
Class II · Moderate risk Terminated
Clobazam Oral Suspension
Reason Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
Class II · Moderate risk Terminated
Temozolomide Capsules
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk Terminated
Temozolomide Capsules
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk Terminated
Temozolomide Capsules
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk Terminated
Temozolomide Capsules
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk Terminated
Temozolomide Capsules
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk Terminated
Temozolomide Capsules
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk Terminated
CVS Health Children's Nasal Saline Drops with Himalayan Salt…
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk Terminated
DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk Terminated
CVS Health Children's Allergy Relief Liquid Medication…
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk Terminated
LA FRESH travel lite Sunnyside Lotion Wipe silky
Reason 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 Terminated
Fungo Off Capsules
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Asma Stopper Capsules
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Anemia Off
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Appetrol Capsules
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Mental Tonic Capsules
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Thyro-Lo
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Smoke End Capsules
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Detensin
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Yeast Douche Powder
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Worm Off
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.