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Issue Date | Manufacturer | Product Name(s) | Ingredient(s) | Issuing Office | Potential Violation(s) | Regulations Cited for Violation | Response Letter Posted | Link to FDA Warning Letter | FDA's Warning Letter Number | Response Letter Link |
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07/27/2009 | American Cellular Labs | TREN-Xtreme, MASS Xtreme, ESTRO Xtreme, AH-89-Xtreme, HMG Xtreme, MMA-3 Xtreme, VNS-9 Xtreme, TT-40-Xtreme | 19-Norandrosta-4,9-diene-3,17 dione, 17a-methyletioallocholan-2-ene-17b-ol, 4-hydroxyandrostenedione (4-0HA), 5a-androstano[3,2-c]pyrazole-3-one-17B-ol-THP-ether, 2a,3a-epithio-17a-methyl-17B-hydroxy-5a-etioallocholane, Androsta-1,4-dien-3,17-dione, 17a-methyl-4-chloro-androsta-I,4-diene3B,17B-diol, 1-androsterone | San Francisco District Office | Misbranded:Unapproved New Drug | 21 U.S.C. 321(g), 21 U.S.C. 321(p), 21 U.S.C. 352(f), 21 U.S.C. 355(a), 21 CFR 201.5, 21 U.S.C. 353(b), 21 U.S.C. 352(a), 21 U.S.C. 332, 21 U.S.C. 334 | No | http://www.fda.gov/iceci/enforcementactions/warningletters/2009/ucm173874.htm | None given |