Provision Health Corp. dba PH Labs — Class II: Ocular Plus with Lutein, Zeaxanthin, and Omega 3-6-9; Dietary Supplement, 200 Capsules. Se
Provision Health Corp. dba PH Labs has initiated a Class II recall for 'Ocular Plus with Lutein, Zeaxanthin, and Omega 3-6-9' dietary supplement capsules. The recall was issued due to the presence of undeclared Yellow #5 in the product.
This recall affects dietary supplement manufacturers, specifically those distributing vision-support formulations, as well as regulatory and quality compliance departments responsible for labeling accuracy.
The failure to declare Yellow #5 is a regulatory non-compliance that triggers misbranding concerns. For regulatory professionals, this underscores the necessity of rigorous ingredient reconciliation between formulation specifications and final packaging labels, as undeclared color additives are a common focal point for FDA enforcement actions in the supplement sector.
QA teams should verify that all color additives present in raw materials or finished formulations are reflected on the supplement facts panel and ingredient statement. Regulatory departments should audit product labels for compliance with FD&C Act requirements regarding declared colorants to prevent misbranding.
Class II. Reason: Dietary supplement product Ocular Plus contains undeclared Yellow#5.. Product: Ocular Plus with Lutein, Zeaxanthin, and Omega 3-6-9; Dietary Supplement, 200 Capsules. Serving Size: 4 Capsules; Distributed by: L.A. Farmacia Natural, Burbank, CA 91504 UPC: PHF-C023. Firm: Provision Health Corp. dba PH Labs (San Diego CA United States). Status: Ongoing.
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