FDA recall D0034-2015

Product

Whitfield's OINTMENT B.P., Net Contents: 15g. Manufactured by: NEW GPC INC. A1 Farm, EBD. 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=D0034-2015