FDA (Drugs) recall action 69206
The FDA (Drugs) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.
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..
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.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
New Gpc Inc. is recalling Mustarcreme units in New York because the product lacks required drug listings, OTC labeling, and is marked not approved for U.S. sale.
New GPC Inc. is recalling Alcosulph Astringent Lotion because it lacks required drug listings and OTC labeling, and is labeled as not approved for sale in the U.S.
New GPC Inc. is recalling Alcosulph Moisturizing Cream because it lacks required OTC drug listings and labeling, and is marked not approved for sale in the U.S.
New Gpc Inc. is recalling Rector's Remedy Ointment because the product lacks required drug listings and OTC labeling.
New GPC Inc. is recalling 360 units of Whitfield Lotion in New York because the product lacks required OTC drug listing and labeling.
New GPC Inc. is recalling Ferrol Expectorant because the product lacks required OTC drug listings and labeling, and is labeled as not approved for sale in the U.S.
New GPC Inc. is recalling 4,320 units of Whitfield's Ointment B.P. in New York due to missing drug listings and non-compliant labeling.