October 31, 2013

Re: Recall of Xylanase Enzyme Products


Our manufacturer has today alerted us of a recall of ALL enzyme products containing xylanase. Some lots of xylanase were found to contain small amounts of the antibiotic, chloramphenicol. While Houston Enzyme's products may not be affected, our manufacturer has decided, out of an abundance of caution, to issue the recall of all xylanase-containing products. This recall affects most every U.S. enzyme company as the material was contaminated at the production level overseas.

Please note the following lot numbers for the products TriEnza and No-Fenol. This applies to capsules, chewable tablets, and powder forms of these products. If you have remaining inventory with these lot numbers, please remove and quarantine. Call our office at 866-757-8627 to arrange for shipping of product back to Houston Enzymes. You will be issued a credit for returned product and shipping charges.

Our manufacturer has received new batches of xylanase raw material and is rush-ordering our replacement products. We anticipate having product back in house by November 15.

Please note that AFP Peptizyde, Zyme Prime and Lypazyme are NOT affected by the recall.

Houston Enzymes is committed to the health and well-being of our customers. While the recall is not an immediate health concern, it is imperative that you cooperate with the recall process to ensure that contaminated lots of product are no longer distributed. To date, we have received no adverse event notices from use of the noted lots of products. If you have received such notices, please forward to our office.

No-Fenol Capsules

52437042
52437043
52437044
52437045
52437046
52437047
52437048
52437049
52437050
52437051
52437052
52437053
52437054
91456000

TriEnza Capsules
53379030 53379031 53379032 53379034
53379035 53379036 53379037 53379038
53379039 53379040 53379041 53380081
53380083 53380085 53380086 53380087
53380088 53380089 53380090 53380091
53380092 53380093 53380094 53380095
53380096 53380097 53380098 53380099
53380100 53380101 53380102 53380103
53380104 53380105 53380106 53380107
53380108 53380109 53380110 53380111
53380113 53380114 91980002 91980003

TriEnza Bottled Powder
54045003 54045005 54045006 54045007 54045008

No-Fenol Chewables
54651001 83451000 92566001

I apologize for the inconvenience that this recall has caused. Please be assured I will do everything possible to make amends.


Sincerely,

Devin Houston, Ph.D.
President/CEO
Houston Enzymes
http://www.houston-enzymes.com

Amy Onnen
Office Manager, Houston Enzymes
amy.onnen@houston-enzymes.com
http://www.houston-enzymes.com
Office: 866-757-8627
Fax: 479-549-4540

Second Notice
Dear Valued Customer,
We recently implements a product recall on some product that you have purchased from us. Please see the letter below for more information. Please rely to this e-mail to acknowledge that you have received this notification.

Please call or e-mail us with any questions.

Best regards,

Candi Shuford
Administrative Manager

Enzyme Recall - URGENT
October 11, 2013
Dear Valued Healthcare Provider,

Please be advised that ProThera®, Inc. and Klaire Labs®, a division of ProThera®, Inc.,

are voluntarily recalling the following enzyme products due to detection of small

quantities of the antibiotic chloramphenicol. Adverse health consequences related to the

use of these products are highly unlikely, but supplements should not contain any

detectable amounts of this material. A full investigation is underway.

Product Description: Serralase®

Product Code Number: SRA (90 tablets); SRA180 (180 tablets)

Lot Number: F3994

Product Description: Vital-Zymes™ Chewable

Product Code Number: K-VCH

Lot Numbers: F3990 & C3516

Product Description: Vital-Zymes™ Complete

Product Code Number: K-VZM

Lot Numbers: 0613110, 0513156 & 0513157

Product Description: InterFase®

Product Code Number: K-INT (60 capsules); K-INT-12 (120 capsules)

Lot Numbers: 0313127

Product Description: InterFase Plus®

Product Code Number: K-INTP

Lot Numbers: 0913039 & 0413085

Our records indicate that you have received these products. Immediately examine your

inventory and determine if these products are in your possession. If so, please

discontinue the use of the products and discard them. For product sold to your patients,

instruct them to immediately discontinue its use and discard them.

You will receive full credit for any product discarded. Please email us at

customerservice@protherainc.com with a summary of discarded product for credit, or

contact our Customer Service Department at 1-775-850-8800 with any questions.

We deeply appreciate and value the trust you have placed in ProThera®, Inc. and Klaire

Labs®, a division of ProThera®, Inc. by purchasing these enzyme products and

apologize for any inconvenience this product recall may cause.

If you have any questions or comments concerning this recall, please call us toll free

directly at 1-775-850-8800. We will keep you informed of the outcome of our

investigations and will notify you when a new lot of product is available.

Sincerely,

Stephen Olmstead, MD

Chief Science Officer

ProThera, Inc.
10439 Double R Blvd.
Reno, NV 89521
775-850-8800 x100 Voice
775-850-8810 Fax
888-488-2488 Toll-Free
http://www.ProTherainc.com