Food recall

ProThera, Inc. recall: Klaire Labs Ther-Biotic FACTOR 6 100+ Billion CFU's Multi-Species Probiotic Supplement 60 Vegetarian Capsules

ProThera, Inc., of Reno, NV, recalled Klaire Labs Ther-Biotic FACTOR 6 100+ Billion CFU's Multi-Species Probiotic Supplement 60 Vegetarian Capsules and 1 other product. The FDA's 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.” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on March 13, 2015, and the FDA first listed it in its Enforcement Report of April 22, 2015. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class II

It could cause temporary or minor harm

Why

Metal, plastic, glass or other objects

Status

Terminated

Closed July 1, 2015

The recall

Company
ProThera, Inc. (Reno, NV)
Reason, in FDA's words
“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.”
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.
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
70761

The 2 products recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-1953-2015 Class II

    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.

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

    Quantity: lot H4496 = 1,337 total bottles; lot K4780 = 1,336 total bottles

  • F-1954-2015 Class II

    Klaire Labs Ther-Biotic Children's Chewable 125+ Billion CFU's Multi-Species Probiotic Supplement 60 Chewable Capsules. UPC 7 09616 01247 5 Manufactured by ProThera Inc . Klaire Labs is a division of ProThera, Reno, NV.

    Codes: K-TCC (60 capsules) Lot Number: J4694, Exp 12/15

    Quantity: 3,484 total bottles

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of April 22, 2015.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.