POLY-TUSSIN AC LIQUID — Class III drug recall D-1431-2014
Terminated recall by Poly Pharmaceuticals, Inc, reported 2014-07-23, distributed nationwide. Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inacc
| Recall number | D-1431-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Poly Pharmaceuticals, Inc, Owens Cross Roads, AL, United States |
| Recall initiated | 2014-06-26 |
| Classified | 2014-07-11 |
| Reported by FDA | 2014-07-23 |
| Terminated | 2014-11-03 |
| Distributed | Nationwide (US) |
| Quantity | 208 bottles |
| Reason classes | labeling |
| NDC | 50991-0713-16 |
| Lot numbers | 02/15, 04413 |
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, Mobile, AL 36619. NDC: 50991-713-16.
Reason for recall
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1431-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.