FDA Drug Recalls

Recalls / Class II

Class IID0031-2015

Product

MUSTARCREME, Net Contents: 60g (21 oz) Country of Origin Guyana.

Affected lot / code info
Batch Numbers: 305150, 312236, 311231

Why it was recalled

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..

Recalling firm

Firm
New Gpc Inc.
Notification channel
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Type
Voluntary: Firm initiated
Address
Lot A1, Farm, East Bank Demerara, N/A, Guyana

Distribution

Quantity
1320 units
Distribution pattern
New York

Timeline

Recall initiated
2014-08-07
FDA classified
2014-10-17
Posted by FDA
2014-10-29
Terminated
2018-06-04
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D0031-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls