American Sales Company Inc – FDA Warning Letter, Jul 16, 2019
The FDA issued a Warning Letter to American Sales Company on July 11, 2019, regarding inaccuracies in their listing for diphenhydramine hydrochloride and zinc acetate (NDC 41520-090). The review revealed two primary violations:
1. **Inaccurate Active Ingredient Listing:** The electronic listing file incorrectly identified the active ingredient as "bromodiphenhydramine hydrochloride," while the product labeling correctly stated "diphenhydramine hydrochloride." This violates 21 CFR Part 207.49(a)(4), which requires the listing to include the correct name and quantity of each pharmaceutical ingredient.
2. **Mismatched National Drug Code (NDC):** The NDC on the label copy provided in the listing was "00000-000-00," which did not match the NDC "41520-090" in the electronic listing file. FDA regulations (FD&C Act Section 510(j)(1)(C), 21 C.F.R. 207.33(d)(i), and 207.49(a)(1)) require a consistent NDC for each drug and its versions.
These deficiencies were previously communicated to the company on March 19, 2019, and a data removal notification was sent on May 3, 2019,
ID · fd88e26e-a083-4cea-ac1f-fbfdc676ea96
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.