Recalls / Class II
Class IID0034-2015
Product
Whitfield's OINTMENT B.P., Net Contents: 15g. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.
- Affected lot / code info
- Batch Numbers: 202504, 310455
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
- 4320 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 D0034-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.