FDA-Drug2014-07-23Class III
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.
Poly Pharmaceuticals, Inc
Hazard
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Sold states
U.S. Nationwide
Affected count
102 Bottles
Manufactured in
2720 Cullom Blvd Se, N/A, Owens Cross Roads, AL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1432-2014Don't want to check this manually?
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