FDAFDA · Food and drugs·Recall number D-1432-2014
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.
Published July 23, 2014 · Recall initiated: June 26, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Poly Pharmaceuticals, Inc
- Distributor
- U.S. Nationwide
- Lot
- Lot #: 03613, Expiry: 02/15
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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