D0030-2015 Class II Terminated
FDA drug recall D0030-2015 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: 900 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
- 900 units
Product Description
alcosulph Astringent Lotion, Net Contents: 1) 60 mL and 2) 120 mL. Product packaged within a glass container individually placed in small carton. 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: 304159, 211463, 308345