# FDA recall D-1432-2014

> **Poly Pharmaceuticals, Inc** · Class III · drug recall initiated 2014-06-26.

## 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: 50991-515-16.

## Reason for recall

Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-1432-2014
- **Recalling firm:** Poly Pharmaceuticals, Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-06-26
- **Report date:** 2014-07-23
- **Termination date:** 2014-11-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Owens Cross Roads, AL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1432-2014

## Citation

> AI Analytics. FDA recall D-1432-2014. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-1432-2014. Source: US FDA. Licensed CC0.

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