FDA Food Recalls

Recalls / Class II

Class IIF-1953-2015

Product

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.

Type
Food
Affected lot / code info
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

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.

Recalling firm

Firm
ProThera, Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
10439 Double R Blvd, N/A, Reno, Nevada 89521-8905

Distribution

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

Timeline

Recall initiated
2015-03-13
FDA classified
2015-04-14
Posted by FDA
2015-04-22
Terminated
2015-07-01
Status
Terminated

Source: openFDA Food Enforcement endpoint. Recall record F-1953-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings.