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Class II: temporary or reversible health riskTerminated

ProThera Klaire Labs Ther-Biotic FACTOR 6 100+ Recall

Klaire Labs Ther-Biotic FACTOR 6 100+ Billion CFU's Multi-Species Probiotic Supplement…

ProThera, Inc. · Reno, NV

Risk level
Class II
Reported by FDA
Apr 22, 2015
Recall ID
F-1953-2015
Check your lot numberHow we source this data

Summary

ProThera recalled Klaire Labs Ther-Biotic FACTOR 6 100+ starting Mar 13, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report F-1953-2015 on Apr 22, 2015. Reason: Firm is recalling three lots of Ther-Biotic dietary supplements due to reports of shards of blue glass found in the bottles, not the in supplement. Status: Terminated.

Why it was recalled

Firm is recalling three lots of Ther-Biotic dietary supplements due to reports of shards of blue glass found in the bottles, not the in supplement.

Product description

Klaire Labs Ther-Biotic FACTOR 6 100+ Billion CFU's Multi-Species Probiotic Supplement 60 Vegetarian Capsules. UPC 7 09616 01248 2 Manufactured by ProThera Inc . Klaire Labs is a division of ProThera, Reno, NV.

Lot numbers, UPCs & expiration codes

K-TF6 (60 capsules) Lot Number: H4496, Exp 10/15 and K4786, Exp 1/16.

Where it was sold

Nationwide and to Azerbaijan, Canada, China, Germany, Great Britain,Hong Kong, Indonesia, Japan, Malaysia, Mexico, Panama, Russia, Singapore, Spain, Switzerland, Ukraine.

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
F-1953-2015
Classification
Class II
Status
Terminated
Recall initiated
Mar 13, 2015
FDA report date
Apr 22, 2015
Quantity
lot H4496 = 1,337 total bottles; lot K4780 = 1,336 total bottles
Recall type
Voluntary: Firm initiated
Recalling firm
ProThera, Inc.

Original FDA data

Every field from FDA enforcement report F-1953-2015, exactly as published.

Show all FDA fields
City
Reno
State
NV
Status
Terminated
Country
United States
Event ID
70761
Address
10439 Double R Blvd
Code information
K-TF6 (60 capsules) Lot Number: H4496, Exp 10/15 and K4786, Exp 1/16.
Postal code
89521-8905
Report date
Apr 22, 2015
Product type
Food
Recall number
F-1953-2015
Classification
Class II
Recalling firm
ProThera, Inc.
Product quantity
lot H4496 = 1,337 total bottles; lot K4780 = 1,336 total bottles
Termination date
Jul 1, 2015
Reason for recall
Firm is recalling three lots of Ther-Biotic dietary supplements due to reports of shards of blue glass found in the bottles, not the in supplement.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Klaire Labs Ther-Biotic FACTOR 6 100+ Billion CFU's Multi-Species Probiotic Supplement 60 Vegetarian Capsules. UPC 7 09616 01248 2 Manufactured by ProThera Inc . Klaire Labs is a division of ProThera, Reno, NV.
Distribution pattern
Nationwide and to Azerbaijan, Canada, China, Germany, Great Britain,Hong Kong, Indonesia, Japan, Malaysia, Mexico, Panama, Russia, Singapore, Spain, Switzerland, Ukraine.
Recall initiation date
Mar 13, 2015
Initial firm notification
Letter
Center classification date
Apr 14, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-1953-2015, published Apr 22, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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