FDA recall D0030-2015

New Gpc Inc. · Class II · drug

Product

alcosulph Astringent Lotion, Net Contents: 1) 60 mL and 2) 120 mL. Product packaged within a glass container individually placed in small carton. Country of Origin Guyana.

Reason for recall

Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..

Distribution

New York

Key facts

Status
Terminated
Initiation date
2014-08-07
Report date
2014-10-29
Termination date
2018-06-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
East Bank Demerara, Guyana

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D0030-2015