Poly Pharmaceuticals, Inc recalls LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22.5 mg

Recalled July 23, 2014 · FDA recall D-1432-2014 · 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

102 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

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: 50991-515-16.

Manufacturer(s)

Poly Pharmaceuticals, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →