The Recall Desk

FDA (Drugs) recall action 83492

Unipharma, Llc. recalled 3 products on 2019-08-14

The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2019-08-14
Critical
0
Units
528

Why these products were recalled

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • ModerateFDA (Drugs)··2019-08-14

    Unipharma Recalls DrKids Children's Allergy Relief Diphenhydramine Due to B. cepacia Risk

    Unipharma is recalling DrKids Children's Allergy Relief Diphenhydramine vials due to a precautionary measure regarding potential contamination with B. cepacia bacteria.

    Product
    DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, Mixed berry Flavor, 20 Pre-measured Single-Use vials per Carton, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, UPC 370302255010
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2019-08-14

    CVS Children's Nasal Saline Drops Recalled for B. cepacia Contamination Risk

    Unipharma, LLC is recalling CVS Health Children's Nasal Saline Drops due to a precautionary measure regarding potential contamination with B. cepacia bacteria.

    Product
    CVS Health Children's Nasal Saline Drops with Himalayan Salt Saline Nasal Moisturizer, 30 single-use vials per Carton,0.05 fl. oz. (1.5 mL) each 1.5 fl. oz. (45 mL) total, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2019-08-14

    CVS Children's Allergy Relief Liquid Medication Recalled for Potential B. cepacia Contamination

    Unipharma is recalling CVS Health Children's Allergy Relief Liquid Medication due to potential contamination with B. cepacia bacteria. The recall is a precautionary measure.

    Product
    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 per Carton, 0.17 fl. oz. (5 mL) Each, 3.4 fl. oz. (100 mL) Total Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsock
    Category
    Distribution
    0 states