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U.S. Department of Health and Human Services

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Sterile Talc Powder, Product 1690 - Recall Notice Aug 2000

FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse either the product or the company.


This is the retyped text of a letter from Bryan Corporation. Contact the company for a copy of any referenced enclosures.


URGENT: RECALL - Sterile Talc Powder, Product 1690

Bryan Corporation, Woburn, MA is voluntarily recalling all lots of Sterile Talc Powder, 4 grams in a 100ml amber vial, (Product 1690) as the product may be non-sterile, misbranded and is considered by the FDA to be an unapproved New Drug. Two lots, 9H010 and 9K012 tested non-sterile. Please examine your stock rooms IMMEDIATELY to determine if you have any lots of (Product 1690), Sterile Talc Powder in your inventory. If so, discontinue the use of the product and promptly return via parcel post or UPS marked:

RECALL-RETURN GOODS
BRYAN CORPORATION
4 PLYMPTON STREET
WOBURN, MA 01801
(781) 935-0004

You will be issued credit for any unused product and shipping charges. Please return the enclosed card immediately providing the requested information. This recall is being made with the knowledge of the Food and Drug Administration. All inquires should be directed to the Customer Service Department (800) 343-7711. We appreciate your assistance in this matter.

Sincerely,

Frank Abrano
CEO

 

BRYAN CORPORATION
4 PLYMPTON STREET
WOBURN, MA 01801
(781) 935-0004