The Recall Desk
Agency classClass IIOur severity:SevereFDA (Food)·F-3527-2017·Announced 2017-09-20

Major Poly-Vita Drops Recalled for B. cepacia Contamination

The Harvard Drug Group is voluntarily recalling Major Poly-Vita Drops due to possible B. cepacia contamination, which poses a serious infection risk to immunocompromised patients.

The agency’s classification

FDA (Food): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states the contamination 'may result in serious infections that could be life-threatening,' which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk pathogens with severe potential consequences, warranting a Severe (4) rating.

Plain-English summary

The Harvard Drug Group, along with Leader Brand and Major Pharmaceuticals, is voluntarily recalling Major Poly-Vita Drops, 1 2/3 oz (50 mL). The recall is being initiated due to possible product contamination with B. cepacia.

The contamination may result in serious infections that could be life-threatening for patients with compromised immune systems and those with chronic lung conditions, such as cystic fibrosis. The recall covers 27,735 units of the product, identified by UPC Number 3 09045 09950 6, across all unexpired lots.

The product was distributed nationwide in the United States. Consumers should check their inventory for this specific product and UPC number. If found, they should stop using the product and follow instructions from the recalling firm or their healthcare provider regarding disposal or return.

The recalled product

Product
Major Poly-Vita Drops, 1 2/3 oz (50 mL)
Manufacturer
The Harvard Drug Group
Category
Food — Dietary Supplements
Hazard
Affected units
27,735

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 (4)

  • Major Poly-Vita Drops
  • 1 2/3 oz (50 mL)
  • UPC Number:3 09045 09950 6
  • All Unexpired Lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 recalled by The Harvard Drug Group under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 17 products in this recall →

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