The Recall Desk
HighFDA (Drugs)·D-0438-2023·Announced 2023-03-15

NatraBio Cold and Sinus Nasal Spray Recalled for Manufacturing Deviation

Nutraceutical Corporation is recalling NatraBio Cold & Sinus Nasal Spray (0.8 FL Oz) lot 222016 due to manufacturing deviations and product discoloration. The product was distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is based on manufacturing deviations resulting in product discoloration, which represents a theoretical rather than demonstrated health risk.

Plain-English summary

Nutraceutical Corporation is recalling NatraBio Cold & Sinus Nasal Spray, a homeopathic medicine spray in 0.8 FL Oz (24 mL) bottles. The recall affects lot 222016 with an expiration date of January 2025.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified by the repackager. The raw material used in the product exhibited discoloration, indicating a manufacturing quality issue.

The affected product was distributed nationwide in the USA, with approximately 4,004 units involved in the recall. For questions or concerns, consumers can contact NatraBio at Shelburne Falls, MA 01370 USA.

The recalled product

Product
NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for Healthway Corp. Comments or Questions NatraBio Shelburne Falls, MA 01370 USA, UPC 3 71400 55711 2
Manufacturer
Nutraceutical Corporation
Category
Drug — Homeopathic Nasal Spray
Hazard
  • manufacturing-deviation
  • discoloration

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: 222016
  • Exp: 01/25

Distribution

Distributed nationwide across the United States.

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