Class III means the product is unlikely to cause harm but violates FDA labeling or manufacturing rules. These are the recalls you rarely hear about; pharmacies usually just swap the affected lot.
1,716 recalls, newest first.
This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant.
Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Failed Stability Testing: This product is below specification for preservative content.
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
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.
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Failed Stability Specifications: this product is below specification for preservative content.
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
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.
Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval
Failed Dissolution Specification; 8 hr stability timepoint
Failed Stability Specification; product viscosity and or pH are below specification.
Subpotent. drug
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.
Failed Content Uniformity Specifications; at the 18 month time point.
Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.
Subpotent
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.