Reported Jul 23, 2014 · Terminated
LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22.5…
Poly Pharmaceuticals, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Poly Pharmaceuticals, Inc · 2720 Cullom Blvd Se · Owens Cross Roads, AL · 35763-9309
Is this the product you have?
- LORTUSS EX
- Each 5 mL (1 teaspoonful) contains
Codeine Phosphate 10 mgGuaifenesin 100 mgPsuedoephedrine HCl 22.5 mg16 fl oz. (473 mL)Rx Only
- Manufactured byGreat Southern Laboratories, Houston, TX 77099
- Distributed forPoly Pharmaceuticals, Mobile, AL 36619
- NDC50991-515-16
- Lot codes and dates
- Lot #: 03613
- Expiry02/15
- Amount recalled
- 102 Bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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