D0032-2015 Class II Terminated
FDA drug recall D0032-2015 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, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.… The recall status is terminated (terminated June 4, 2018). Affected quantity: 36 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
- 36 units
Product Description
Ferrol EXPECTORANT, Net Contents: 100 mL. Product packaged within a plastic bottle individually placed in small blue carton. 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 Pattern
New York
Code Information
Batch Numbers: 305206