FDA recall D-1432-2014

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".

Distribution

U.S. Nationwide

Key facts

Status

Terminated

Initiation date

2014-06-26

Report date

2014-07-23

Termination date

2014-11-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Owens Cross Roads, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1432-2014