Poly Pharmaceuticals Recalls Lortuss Ex Due to Labeling and Specification Issues
Poly Pharmaceuticals is recalling 102 bottles of Lortuss Ex because the product does not meet monograph specifications and has inaccurate labeling.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The issues are primarily related to labeling and minor specification deviations.
Plain-English summary
Poly Pharmaceuticals, Inc. is recalling 102 bottles of Lortuss Ex, a prescription cough and cold medication. The product is distributed nationwide in the United States. The specific lot number is 03613, with an expiration date of 02/15.
The recall was initiated because the product does not meet monograph specifications. Specifically, the levels of phenylephrine and pseudoephedrine are below the required standards. Additionally, the label inaccurately contains the wording "Rx Only," despite the product being a prescription item.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The product was manufactured by Great Southern Laboratories and distributed by Poly Pharmaceuticals.
The recalled product
- 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:
- Manufacturer
- Poly Pharmaceuticals, Inc
- Category
- Drug — Cough and Cold Medication
- Affected units
- 102
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 03613
- Expiry: 02/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Poly Pharmaceuticals, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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