Poly Pharmaceuticals, Inc recalls POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate 4 mg, Codeine Phosphate 10 mg, Phenyl
Recalled July 23, 2014 · FDA recall D-1431-2014 · Poly Pharmaceuticals
Hazard
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only". · FDA Class III
Units
208 Bottles
Sold at
U.S. Nationwide
Description
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "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, Mobile, AL 36619. NDC: 50991-713-16.
Manufacturer(s)
Poly Pharmaceuticals, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →