What happened
Original notice title
Andropharm, LLC 6/5/17
From the archived source record
a drug is misbranded if, among other things, it fails to bear adequate directions for its intended use(s). In light of the fact that they are unapproved prescription drugs, the labeling of “Sten Z” and “M1 Alpha” fails to bear adequate directions for the products’ intended uses; therefore, the products are misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. Therefore, the introduction or delivery for introduction, or causing the introduction or delivery for introduction, into interstate commerce of these misbranded products violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts. Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Your written notification should refer to the Warning Letter Number above ( CMS Case # 522784 ). Maxwell Acting Program Division Director Office of Pharmaceutical Quality Operations, Division II CC: Anthony J.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 9bc81a92af7e
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →