FDA recall D-005-2013

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

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

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