ProThera, Inc. recalled this product and the FDA reported the enforcement action on 22 April 2015 as Class II. The recall was initiated by the firm. 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 record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
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.
UPC
709616012482
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.
lot H4496 = 1,337 total bottles; lot K4780 = 1,336 total bottles
Distribution
Nationwide and to Azerbaijan, Canada, China, Germany, Great Britain,Hong Kong, Indonesia, Japan, Malaysia, Mexico, Panama, Russia, Singapore, Spain, Switzerland, Ukraine.
Initiated
13 March 2015
Reported by FDA
22 April 2015
Terminated
1 July 2015
Firm notified by
Letter
Product codes
K-TF6 (60 capsules) Lot Number: H4496, Exp 10/15 and K4786, Exp 1/16.
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
This is one of 2 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 2 separate recalls, which almost every published figure does, overstates it by a factor of 2. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 2 of them.
The recall ran for 4 months, from 13 March 2015 to termination on 1 July 2015. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
The FDA published the enforcement report 6 weeks after the firm began the recall.
Recalls of a dietary supplement run a median of 15 months, so this one was shorter than usual for its category. Dietary supplements are regulated under their own good manufacturing practice rule, 21 CFR part 111, and they are the only food category where the dominant recall reason is an ingredient that was never declared because it is a pharmaceutical.
A foreign material recall means something that is not food was found in food: metal, plastic, glass, wood or insect matter, usually shed by equipment during processing.
A preventive controls plan covers foreign material under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
21 CFR 117.40
Equipment and utensils: plant equipment designed and maintained so it cannot contaminate food with lubricants, fuel, metal fragments or contaminated water.
21 CFR 117.80(c)
Manufacturing operations: the measures that protect food from contamination during processing, including the effective ones against metal and other extraneous material.
21 CFR 117.150
Corrective actions: what a facility does when a preventive control was not properly implemented, including identifying and correcting the problem and evaluating the food for safety.
Other dietary supplements recalls for the same reason
These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
Metal fragments. The potential foreign object is a hard, metal (stainless steel), curled spring. Dimensions of a similar spring measure 2.27mm in cross-sectional thickness and 25.38mm in coil width. Spring ends are not sharp but may be sharp if broken/ cut.
Nestle Product Technology Center - Nestle Health Science
Nestle Health Science (NHS U.S., LLC) is initiating a recall of Douglas Labs Stress-B-Plus Dietary Supplement Tablets, 90 tablets per bottle. The bottle is white and made of plastic. Lot Numbers 50335944,50344396, expiration date 04/11/2026. The product is being recalled because of Incorrect formulation manufactured vs label claims. Product was manufactured with Niacin (as Nicotinic acid) and supplement facts panel states contains Niacin (as Niacinamide).
21 CFR 117.40 is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.
