The Recall Desk
SevereFDA (Food)·F-3529-2017·Announced 2017-09-20

Major Tri-Vita Drops Recalled for Possible B. cepacia Contamination

The Harvard Drug Group is voluntarily recalling Major Tri-Vita Drops due to possible contamination with B. cepacia, which may cause serious infections in vulnerable patients.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the source text explicitly states the contamination may result in serious infections that could be life-threatening, meeting the criteria for a Severe rating.

Plain-English summary

The Harvard Drug Group, along with Leader Brand and Major Pharmaceuticals, is voluntarily recalling Major Tri-Vita Drops, 1 2/3 oz (50 mL). The recall involves 10,074 units of the product, which was distributed nationwide in the United States and to the VA CMOP Charleston facility. The recall is being initiated due to possible product contamination with B. cepacia.

B. cepacia contamination may result in serious infections that could be life-threatening in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. The source text does not specify which lots are affected, noting only "All Unexpired Lots," and does not report any specific illnesses or injuries to date.

Consumers should stop using the recalled product. The source text does not provide specific instructions for disposal or refund procedures, but the recall is voluntary and initiated by the distribution firms.

The recalled product

Product
Major Tri-Vita Drops, 1 2/3 oz (50 mL)
Manufacturer
The Harvard Drug Group
Category
Food — Dietary Supplement
Hazard
Affected units
10,074

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 Tri-Vita Drops
  • 1 2/3 oz (50 mL)
  • UPC Number: 3 09046 27450 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 →

Related recalls

Same manufacturer · The Harvard Drug Group

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Same hazard · b cepacia

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