# FDA recall D00432-2015

> **Qualitest Pharmaceuticals** · Class III · drug recall initiated 2015-03-25.

## Product

PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains:  Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25 mg, Phenylephrine Hydrochloride 5 mg, alcohol 7%, (a) 4 fl oz bottle (NDC 0603-1588-54) and (b) 16 fl oz bottle (NDC 0603-1588-58) Rx only, Manufactured for QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811.

## Reason for recall

Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.

## Distribution

Nationwide

## Key facts

- **Recall number:** D00432-2015
- **Recalling firm:** Qualitest Pharmaceuticals
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-03-25
- **Report date:** 2015-04-15
- **Termination date:** 2016-07-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Huntsville, AL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D00432-2015

## Citation

> AI Analytics. FDA recall D00432-2015. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D00432-2015. Source: US FDA. Licensed CC0.

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