Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration

 

Chicgao District Office
300 South Riverside Plaza
Chicao, IL 60607

July 12, 1991
WARNING LETTER

CERTIFIED MAIL,
RETURN RECEIPT REQUESTED

Mr. Glenn S. Balas, RPh
Sargent’s Drug store
140 E. Walnut
Drake Hotel (basement) Chicago, IL 60611

Dear Mr. Balas:

An inspection of your facility on March 23 & 29, 1991, revealed that you are in serious violation of Section 505 of the Federal Food, Drug, and Cosmetic Act (Act) and Title 21, Code of Federal Regu1ations, Part 314, Applications for FDA Approval to Market a New Drug Or An Antibiotic Drug.

The drug product, Sargenti Root Canal Powder (also referred to as Sargenti Formula), containing prednisolone, hydrocortisone, barium sulfate, titanium dioxide, bismuth subnitrate, paraformaldehyde, bismuth subcarbonate, lead tetraoxide, and zinc oxide, is regarded as a prescription drug in that it meets the criteria set forth in the Act. Sargenti Root Canal Powder is considered a new drug as there is no New Drug Application (NDA) on file for this product showing that it is safe and effective for its intended use.

The Federal Food, Drug, and Cosmetic Act prohibits the introduction or delivery for introduction into interstate commerce any new drug, unless an NDA is effective for such drug.

You should take prompt action to correct these violations. Failure to do so may result in regulatory action without further notice.

You should notify this office in writing within fifteen (15) working days of the receipt of this letter, of the specific steps you have taken to correct these violations. If corrective action cannot be completed within fifteen (15) days, state the reason for the delay and the time within which the corrections will be completed.

Your reply should be directed to the Food and Drug Administration, Chicago District Office, 300 S. Riverside Plaza Suite 550 (south), Chicago, Illinois 60607, Attention: Jerome Bressler, Director, Compliance Branch.

Sincerely,

Raymond V. Mlecko
District Director

This page was posted on October 25, 2007.

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