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.
Reason for recall: Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Recall initiated: 20140626
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated