1,523 recalls · Class III, newest first
Reason Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Reason Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Reason Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
Reason Failed Impurity/degradation Specification
Reason Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Reason Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Reason Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or…
Reason This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which…
Reason This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which…
Reason This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which…
Reason Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant.
Reason Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Reason Failed Stability Testing: This product is below specification for preservative content.
Reason Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
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…
Reason Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Reason Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Reason Failed Stability Specifications: this product is below specification for preservative content.
Reason Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Reason Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Reason Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Reason Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
Reason Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point…
Reason Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval
Reason Failed Dissolution Specification; 8 hr stability timepoint