Agency classClass IIIOur severity:Low FDA (Drugs)·D-1431-2014·Announced 2014-07-23

Poly Pharmaceuticals Recalls Poly-Tussin AC Liquid Due to Labeling and Specification Issues

Poly Pharmaceuticals is recalling 208 bottles of Poly-Tussin AC Liquid because phenylephrine levels are below specifications and the label inaccurately states 'Rx Only'.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, and the issues are primarily related to labeling and minor specification deviations.

Plain-English summary

Poly Pharmaceuticals, Inc. is recalling 208 bottles of Poly-Tussin AC Liquid, 16 fl oz. (473 mL) bottles. The product is a prescription cough syrup containing brompheniramine maleate, codeine phosphate, and phenylephrine HCl. The recall was initiated because the phenylephrine content is below monograph specifications and the label inaccurately contains the wording "Rx Only".

The recalled product is identified by Lot # 04413 and an expiration date of 02/15. It was distributed nationwide in the United States. The product was manufactured by Great Southern Laboratories in Houston, TX, and distributed for Poly Pharmaceuticals in Mobile, AL.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

The recalled product

Product: POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate 4 mg, Codeine Phosphate 10 mg, Phenylephrine HCl 7.5 mg, 16 fl oz. (473 mL) Bottle, Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals…
Manufacturer: Poly Pharmaceuticals, Inc
Category: Drug — Cough and Cold Medication
Hazard: mis-labeling
sub-potent
Affected units: 208

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 #: 04413
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.

See all 2 products in this recall →

Same manufacturer · Poly Pharmaceuticals, Inc

See all →

Low
Poly Pharmaceuticals Recalls Lortuss Ex Due to Labeling and Specification Issues
FDA (Drugs) · 2014-07-23

Same hazard · mis labeling