Spring Valley Biotin & Collagen Liquid, Natural Berry Flavor, 15000 mcg, Dietary…
BioMylz Pvt. Ltd. recalled this product and the FDA reported the enforcement action on 10 January 2024 as Class II. The recall was initiated by the firm. Potential mold contamination
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
- Spring Valley Biotin & Collagen Liquid, Natural Berry Flavor, 15000 mcg, Dietary Supplement 29 doses 1 fl oz (29mL) UPC: 194346065158 Packaged in a glass bottle in a paper carton
- UPC
- 194346065158
- Reason for recall
- Potential mold contamination
- Recalling firm
- BioMylz Pvt. Ltd.
- Firm location
- Bengaluru, N/A, India
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0664-2024
- Quantity
- 24,324 units
- Distribution
- Distributed to a distribution center in CA and then further distributed to distribution centers and retail stores nationwide.
- Initiated
- 1 December 2023
- Reported by FDA
- 10 January 2024
- Terminated
- 18 September 2024
- Firm notified by
- Letter
- Product codes
- NSBS2301, NSBS2302, NSBS2303, NSBS2306, NSBS2308
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 record is the only one the FDA opened for its recall event, so it covers a single product code.
- The recall ran for 10 months, from 1 December 2023 to termination on 18 September 2024. 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 fresh produce run a median of 7 months, so this one was longer than usual for its category. Fresh produce is the category where contamination arrives before the facility does: irrigation water, soil amendments and field workers are the routes, and nothing downstream of the farm is a kill step for a product eaten raw.
What this recall was for
Spoilage and mould
A spoilage recall means the food degraded before its date: mould growth, unintended fermentation, swelling or rancidity, usually traced to a seal, a formulation or a storage temperature.
A preventive controls plan covers spoilage 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 117.93
- Warehousing and distribution: storage and transport under conditions that protect food against contamination and against deterioration of the food and its container.
- 21 CFR 117.80(b)(3)
- Time and temperature: holding food at temperatures that do not allow microorganisms to grow, and for no longer than the process allows.
Filed under fresh produce and dietary supplements. A product can sit in more than one.
Other fresh produce 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.
All 2024 recalls · All FDA food recall data
21 CFR 117.93 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.
Early accessRecall 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.