Home / Recalls / Poly Pharmaceuticals, Inc / D-1432-2014

D-1432-2014 Class III Terminated

Recalled by Poly Pharmaceuticals, Inc — Owens Cross Roads, AL

Recall Details

Product Type: Drugs
Report Date: July 23, 2014
Initiation Date: June 26, 2014
Termination Date: November 3, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 102 Bottles

Product Description

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".

Distribution Pattern

U.S. Nationwide

Code Information

Lot #: 03613, Expiry: 02/15