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CVS Brand Meds Recalled


May 23, 2019

Unipharma is recalling several CVS Health medications for children due to microbial contamination concerns, according to the May 22, 2019, US Food and Drug Administration (FDA) Enforcement Report.

The following products are being recalled:

  • CVS Health Children's Pain & Fever Acetaminophen, 160 mg/5 mL, cherry flavor, 20 single-use vials, 0.17 fl. oz. (5 mL) (NDC 69842-0258-01, UPC 050428601891), from lot 80061 (Exp. 11/30/20);
  • CVS Health Children's Mucus Relief Chest Congestion Plus Cough, dextromethorphan HBr cough suppressant guaifenesin expectorant, mixed berry flavor, 20 single-use vials, 0.17 fl. oz. (5 mL) (NDC 69842-260-01, UPC 050428597675), from lots 80053 (Exp. 10/31/20) and 80055 (Exp. 10/31/20);
  • CVS Health Children's Allergy Relief Liquid Medication, diphenhydramine HCl 12.5 mg/5 mL, oral solution antihistamine, mixed berry flavor, 20 single-use vials, 0.17 fl. oz. (5 mL) (NDC 69842-261-01, UPC 050428597156), from lots 80058 (Exp. 11/30/20) and 80059 (Exp. 11/30/20);
  • CVS Health Children's Cough Syrup English Ivy Leaf, daytime relief, natural pineapple flavor, 20 single-use vials, 0.08 fl. oz. (2.5 mL) (UPC 050428597958), from lots 80043 (Exp. 07/05/20) and 80047 (Exp. 07/31/20);
  • CVS Health Children's Nasal Saline Drops with Himalayan salt saline nasal moisturizer, 30 single-use vials, 0.05 fl. oz. (1.5 mL) (UPC 050428598207), from lots 0026 (Exp. 05/31/20) and 80027 (Exp. 07/31/20); and
  • CVS Health Children's Cough & Chest Congestion DM, dextromethorphan HBr, 5 mg, cough suppressant guaifenesin 100 mg expectorant, mixed berry flavor, 20 single-use vials, 0.17 fl. oz. (5 mL) (NDC 69842-262-01, UPC 050428598368), from lots 80054 (Exp. 10/31/20) and 80056 (Exp. 10/31/20).

All recalled medications were distributed throughout the United States and in Venezuela by CVS Pharmacy.

Unipharma voluntarily initiated the recalls May 2, 2019. At press time, the FDA had not yet classified the recalls.

Jolynn Tumolo

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