The Recall Desk

FDA (Drugs) recall action 68671

Poly Pharmaceuticals, Inc recalled 2 products on 2014-07-23

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
2014-07-23
Critical
0
Units
310

Why these products were recalled

Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".

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

  • LowFDA (Drugs)··2014-07-23

    Poly Pharmaceuticals Recalls Poly-Tussin AC Liquid Due to Labeling and Specification Issues

    Poly Pharmaceuticals is recalling 208 bottles of Poly-Tussin AC Liquid because phenylephrine levels are below specifications and the label inaccurately states 'Rx Only'.

    Product
    POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate 4 mg, Codeine Phosphate 10 mg, Phenylephrine HCl 7.5 mg, 16 fl oz. (473 mL) Bottle, Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals,
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2014-07-23

    Poly Pharmaceuticals Recalls Lortuss Ex Due to Labeling and Specification Issues

    Poly Pharmaceuticals is recalling 102 bottles of Lortuss Ex because the product does not meet monograph specifications and has inaccurate labeling.

    Product
    LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22.5 mg, 16 fl oz. (473 mL), Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC:
    Category
    Distribution
    0 states