The Recall Desk

FDA (Drugs) recall action 83195

H J Harkins Company Inc dba Pharma Pac recalled 2 products on 2019-07-03

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
2019-07-03
Critical
0
Units
52

Why these products were recalled

Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

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

  • SevereFDA (Drugs)··2019-07-03

    Acetaminophen Children's Liquid Recalled for Microbial Contamination Risk

    H J Harkins Company is recalling 40 bottles of Acetaminophen Children's Liquid due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0309-04
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-07-03

    Diphenhydramine Liquid Recalled for Potential Microbial Contamination

    H J Harkins Company is recalling Diphenhydramine HCL Liquid due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.
    Category
    Distribution
    0 states