Class II · Moderate risk
J-TAN D PD Drops
Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40.
Allergy & Cold Medication Recalls
Recalls of antihistamines, decongestants and nasal sprays.
314 recalls in this category, newest first.
Class II · Moderate risk
Loratadine active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Fluticasone Propionate active pharmaceutical ingredient packaged…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Cetirizine HCI active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Diphenhydramine
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Class III · Low risk
PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Class III · Low risk
PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Class III · Low risk
Children's Triacting Night Time Cold & Cough with PE
Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.
Class III · Low risk
Children's Cetirizine Hydrochloride Chewable Tablets
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Class III · Low risk
Cetirizine Hydrochloride Chewable Tablets
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Class III · Low risk
Advil PM Caplets
Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Class II · Moderate risk
Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant
Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.
Class III · Low risk
Cetirizine Hydrochloride Syrup
Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Class III · Low risk
Loratadine 24 HR-OTC
Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.
Class III · Low risk
Loratadine
Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken tablets.
Class II · Moderate risk
Cetirizine HCL
Labeling: Label Mixup: CETIRIZINE HCL, Tablet, 5 mg may have potentially been mislabeled as the following drug: LITHIUM CARBONATE ER, Tablet, 300 mg, NDC 00054002125, Pedigree: AD39564_1, EXP: 5/13/2014.
Class II · Moderate risk
LORATADINE Tablet
Labeling: Label Mixup; LORATADINE Tablet, 10 mg may be potentially mislabeled as GLYCOPYRROLATE, Tablet, 2 mg, NDC 00603318121, Pedigree: W002650, EXP: 6/5/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 05445800022, Pedigree: AD21858_4, EXP: 5/1/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W003217, EXP: 6/14/2014.
Class II · Moderate risk
FEXOFENADINE HCl Tablet
Labeling: Label Mixup; FEXOFENADINE HCL Tablet, 60 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 51645090901, Pedigree: W003019, EXP: 6/12/2014; NIACIN TR, Capsule, 500 mg, NDC 00904063160, Pedigree: AD60240_17, EXP: 5/22/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: AD46257_13, EXP: 5/15/2014.
Class II · Moderate risk
Fexofenadine HCL
Labeling: Label Mixup; FEXOFENADINE HCL Tablet, 180 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 00536406001, Pedigree: AD62992_8, EXP: 5/23/2014.
Class II · Moderate risk
diphenhydrAMINE HCl
Labeling: Label Mixup; diphenhydrAMINE HCl, Tablet, 25 mg may be potentially mislabeled as ATORVASTATIN CALCIUM, Tablet, 40 mg, NDC 00378212177, Pedigree: AD33897_10, EXP: 5/9/2014; ATORVASTATIN CALCIUM, Tablet, 10 mg, NDC 00378201577, Pedigree: W002774, EXP: 6/6/2014; PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree: W003511, EXP: 6/21/2014; VENLAFAXINE, Tablet, 25 mg
Class II · Moderate risk
Pseudoephedrine HCL
Labeling: Label Mixup; PSEUDOEPHEDRINE HCL, Tablet, 60 mg may be potentially mislabeled as REPAGLINIDE, Tablet, 1 mg, NDC 00169008281, Pedigree: W002855, EXP: 6/7/2014.
Class II · Moderate risk
Pseudoephedrine HCL
Labeling: Label Mixup; PSEUDOEPHEDRINE HCL, Tablet, 30 mg may be potentially mislabeled as D-ALPHA TOCOPHERYL ACETATE, Capsule, 400 units, NDC 49348041010, Pedigree: AD52993_28, EXP: 5/20/2014.
Class II · Moderate risk
NeoCitran
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
NeoCitran Extra Strength
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
Theraflu Nighttime Severe Cold & Cough
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
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