drugs Class III Updated 2014-07-23

Poly Pharmaceuticals, Inc recalls LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phos

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 03613, Expiry: 02/15
View official government recall

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