Recalls / Class II
Class IID0030-2015
Product
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.
- Affected lot / code info
- Batch Numbers: 304159, 211463, 308345
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
- 900 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 D0030-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.