# FDA recall D-005-2013

> **Actavis Mid Atlantic LLC** · Class III · drug recall initiated 2012-08-14.

## Product

Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic, LLC., 1877 Kawaii Road, Lincolnton, NC, 28092, USA, NDC 0472-1628-16.

## Reason for recall

Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.

## Distribution

Nationwide & Puerto Rico

## Key facts

- **Recall number:** D-005-2013
- **Recalling firm:** Actavis Mid Atlantic LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-08-14
- **Report date:** 2012-10-17
- **Termination date:** 2013-06-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lincolnton, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-005-2013

## Citation

> AI Analytics. FDA recall D-005-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-005-2013. Source: US FDA. Licensed CC0.

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