D0035-2015 Class II Terminated
FDA drug recall D0035-2015 was initiated by New Gpc Inc. on August 7, 2014 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated June 4, 2018). Affected quantity: 2,304 units.
Recall Details
- Product Type
- Drugs
- Report Date
- October 29, 2014
- Initiation Date
- August 7, 2014
- Termination Date
- June 4, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,304 units
Product Description
Rector's Remedy OINTMENT, 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 and lack of OTC drug labeling requirements.
Distribution Pattern
New York
Code Information
Batch Numbers: 311478, 305207