Class III · Low risk Terminated
Qnasl
Reason Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Ketoconazole Cream
Reason Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Class III · Low risk Terminated
BuPROPion Hydrochloride Extended-Release Tablet
Reason Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Class III · Low risk Terminated
Fluconazole Oral Suspension
Reason Failed Stability Specifications: this product is below specification for preservative content.
Class III · Low risk Terminated
Namenda XR
Reason Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Class III · Low risk Terminated
Namenda XR
Reason Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Class III · Low risk Terminated
Namenda XR
Reason Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Class III · Low risk Terminated
Paclitaxel Injection
Reason Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
Class III · Low risk Terminated
Bumetanide Tablets USP 0.5 mg. Rx Only
Reason Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.
Class III · Low risk Terminated
Glipizide XL
Reason Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval
Class III · Low risk Terminated
Glucotrol XL
Reason Failed Dissolution Specification; 8 hr stability timepoint
Class III · Low risk Terminated
Acyclovir Oral Suspension
Reason Failed Stability Specification; product viscosity and or pH are below specification.
Class III · Low risk Terminated
Ciclopirox Shampoo 1%
Reason Subpotent. drug
Class III · Low risk Terminated
Potassium Chloride
Reason Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mEq and 10 mEq strength instead of the potassium chloride 10 mEq and 20 mEq strength was packaged with the product.
Class III · Low risk Terminated
G & W Fluocinolone Acetonide Cream USP 0.025%
Reason Failed Content Uniformity Specifications; at the 18 month time point.
Class III · Low risk Terminated
Hydroxychloroquine Sulfate Tablets
Reason Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.
Class III · Low risk Terminated
Ketoconazole Shampoo
Reason Subpotent
Class III · Low risk Terminated
Acanya
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an incorrect expiration date assigned to a lot of physicians samples.
Class III · Low risk Terminated
Endometrin
Reason Discoloration; due to prolonged heat exposure.
Class III · Low risk Terminated
Venlafaxine
Reason Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
Class III · Low risk Terminated
Loratadine 24 HR-OTC
Reason Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.
Class III · Low risk Terminated
Timolol Maleate Sterile Ophthalmic Solution
Reason Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Class III · Low risk Terminated
Timolol Maleate Sterile Ophthalmic Solution
Reason Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Class III · Low risk Terminated
Timolol Maleate Sterile Ophthalmic Solution
Reason Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Class III · Low risk Terminated
Timolol Maleate Sterile Ophthalmic Solution
Reason Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.