FDA Drug Recalls

Recalls / Class II

Class IID0035-2015

Product

Rector's Remedy OINTMENT, Net Contents: 15g. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.

Affected lot / code info
Batch Numbers: 311478, 305207

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 and lack of OTC drug labeling requirements.

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
2,304 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 D0035-2015. 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