Recalls of antihistamines, decongestants and nasal sprays.
320 recalls in this category, newest first.
Reason Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
Reason Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
Reason Lack of sterility assurance.
Reason Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40.
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Reason Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Reason Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Reason Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.
Reason Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Reason Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Reason Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Reason Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release…
Reason Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Reason Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.
Reason Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken tablets.
Reason Labeling: Label Mixup: CETIRIZINE HCL, Tablet, 5 mg may have potentially been mislabeled as the following drug: LITHIUM CARBONATE ER, Tablet, 300…
Reason Labeling: Label Mixup: DESLORATADINE, Tablet, 5 mg may have potentially been mislabeled as the following drug: ASCORBIC ACID, Tablet, 250 mg, NDC…
Reason Labeling: Label Mixup; LORATADINE Tablet, 10 mg may be potentially mislabeled as GLYCOPYRROLATE, Tablet, 2 mg, NDC 00603318121, Pedigree: W002650…
Reason Labeling: Label Mixup; FEXOFENADINE HCL Tablet, 60 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 51645090901, Pedigree…
Reason Labeling: Label Mixup; FEXOFENADINE HCL Tablet, 180 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 00536406001…
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