Class II · Moderate risk
Narcan (naloxone HCl)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Allergy & Cold Medication Recalls
Recalls of antihistamines, decongestants and nasal sprays.
314 recalls in this category, newest first.
Class I · High risk
ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray
Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast
Class I · High risk
STIMATE (desmopressin acetate)
Superpotent Drug
Class I · High risk
Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL
Superpotent Drug
Class I · High risk
DDAVP Nasal Spray
Superpotent Drug
Class III · Low risk
Discount Drug Mart
Labeling: Incorrect or Missing Lot and/or Expiration date.
Class II · Moderate risk
Fexofenadine HCl Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg
Failed Stability Specifications.
Class II · Moderate risk
Allergy (Fexofenadine Hydrochloride)
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Wal-Fex (Fexofenadine Hydrochloride)
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Allergy (Fexofenadine Hydrochloride)
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Fexofenadine HCL Tablets USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Fexofenadine Hydrochloride Tablets USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Allergy Relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Fexofenadine Hydrochloride Tablets USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
fexofenadine hydrochloride tablets USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Allergy Relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Allergy Relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Fexofenadine Hydrochrloride Tablets USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
CVS Health Children's Allergy Relief Liquid Medication…
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
Equate Night-time Sleep Aide
Microbial contamination of non-sterile product
Class II · Moderate risk
Diphenhydramine HCL Liquid
Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Diphenhydramine 25 Mg/50 Ml Ns
Lack of Assurance of Sterility
Class II · Moderate risk
Cetirizine Oral Solution 1 mg/mL
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
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