1,523 recalls · Class III, newest first
Reason Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead…
Reason Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
Reason Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Reason Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is…
Reason Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Reason Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Reason Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Reason Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
Reason Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Reason Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Reason Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.
Reason Failed Impurity/Degradation Specification; 12-month stability time point
Reason Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Reason Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.
Reason Failed Dissolution Specification; at the 12 month time interval.
Reason Failed Impurities/Degradation Specifications: out of specification impurity test results.
Reason Failed Impurities/Degradation Specifications: out of specification impurity test results.
Reason Failed Impurities/Degradation Specifications: out of specification impurity test results.
Reason Failed Impurities/Degradation Specifications: out of specification impurity test results.
Reason Stability Data Does Not Support Expiry
Reason Labeling: Incorrect or Missing Package Insert
Reason Labeling: Incorrect or Missing Package Insert
Reason Labeling: Incorrect or Missing Package Insert
Reason Failed Stability Specification; out of specification result for particle size distribution during stability testing
Reason Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.