Inspections, Compliance, Enforcement, and Criminal Investigations
Unisource, Inc. 2/17/10
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Denver District Office
Building 20 - Denver Federal Center
P,O. Box 25087
Denver, Colorado 80225-0087
February 17, 2010
VIA FED EX
Mr. Robert S. Tutag
P.O. Box 684
901 W. Beaver Creek Blvd, #100
Avon, CO 81620
Reference No.: DEN-10-06 CIWL
Dear Mr. Tutag:
(b)(4) These drug products include, but are not necessarily limited to:
• Dicel DM Suspension (Chlorpheniramine Tannate - equivalent to Chlorpheniramine base 2.25 mg/5 mL; Dextromethorphan Tannate - equivalent to Dextromethorphan base 10.5 mg/5 mL; Pseudoephedrine Tarmate - equivalent to Pseudoephedrine base 21.75 mg/5 mL)
• Dicel Supspension (Chlorpheniramine Tannate - equivalent to Chlorpheniramine Base 2.25 mg/5 mL; Pseudeophedrine Tannate - equivalent to Pseudoephedrine Base 21.75 mg/5 mL)
The above products are drugs within the meaning of section 201(g) of the Act, [21 U.S.C. § 321(g)] because, as demonstrated by their labeling, they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases. Further, they are "new drugs" within the meaning of section 201 (p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under sections 301(d) and 505(a)of the Act [21 U.S.C. §§ 331 (a), (d) and 355(a)], a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under either section 505(b) or (j) of the Act [21 U.S.C. § 355(b) or (j)] is in effect for the drug. Based on our information, there are no FDA-approved applications on file for these drug products.
Additionally, because the above prescription drug products are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for them so that a layman can use these products safely for their intended uses, as described in 21 C.F.R. § 201.5. Consequently, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. Because the products lack required approved applications, they are not exempt under 21 C.F.R. § 201.115 from. the requirements of section 502(f)(1) of the Act. The introduction or delivery for introduction into interstate commerce of these products without approved new drug applications violates section 301 (a) and (d) of the Act [21 U.S.C. §§ 331(a) and (d)].
(b)(4) the above drug products are adulterated, 21 U.S.C. 351(a)(2)(B), and thus your firm may not introduce or deliver them for introduction into interstate commerce, 21 U.S.C. § 331 (a).
The violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. In particular, violations cited in this letter are not necessarily limited to drug products manufactured (b)(4) and may apply to all drug products that you market without FDA-approved applications. 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. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.
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 Waming 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 that 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. If you cannot complete corrective action within fifteen working days, state the reason for the delay ana the time within which you will complete the correction. If you no longer market the above products, your response should so indicate, including the reasons that, and the date on which, you ceased production.
Your reply should be sent to U. S. Food and Drug Administration, Attention: Nancy G. Schmidt, Compliance Officer, at the above address. If you have questions regarding any, issue this letter, please contact Ms. Schmidt at (303) 236-3046.
H.Thomas Warwick, Jr.
Denver District Director