The Recall Desk

FDA (Drugs) recall action 83881

Unipharma, Llc. recalled 2 products on 2019-10-16

The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2019-10-16
Critical
0
Units
600

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.

1–2 of 2

  • ModerateFDA (Drugs)··2019-10-16

    DrKids Children's Natural Cough Syrup Recalled for Potential B. cepacia Contamination

    Unipharma, LLC is recalling DrKids Children's Natural Cough Syrup due to a precautionary measure regarding potential contamination with B. cepacia bacteria.

    Product
    DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL) Each 3.4 fl. oz. (100 mL), Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321 UPC 370302489026
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-10-16

    DrKids Himasal Nasal Saline Recalled for Potential B. cepacia Contamination

    Unipharma is recalling DrKids Himasal Natural Nasal Saline Solution vials due to a precautionary measure regarding potential contamination with B. cepacia bacteria.

    Product
    DrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-Use Vials a) 0.5 mL Each (20 count) UPC 37030244608; b) 1.5 mL Each (20 count) UPC 370302446098, Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321
    Category
    Distribution
    0 states