Major CertaVite Liquid Recalled for Possible B. cepacia Contamination
The Harvard Drug Group is voluntarily recalling Major CertaVite Liquid due to possible B. cepacia contamination, which poses a risk of serious infection to patients with compromised immune systems or chronic lung conditions.
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 that the contamination 'may result in serious infections that could be life-threatening,' which aligns with the rubric criterion for 'significant injury' reports or high-risk pathogens with severe potential outcomes, warranting a score of 4.
Plain-English summary
The Harvard Drug Group, along with Leader Brand and Major Pharmaceuticals, is voluntarily recalling Major CertaVite Liquid, 8 oz. (236 mL). The recall involves 61,262 units of the product, which was distributed nationwide in the United States and to the VA CMOP Charleston facility. The recall covers all unexpired lots of the product, identified by UPC Number 3 09045 02309 9.
The recall is being initiated due to possible product contamination with B. cepacia. This bacterium 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.
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions. The product is a dietary supplement, and the specific risk is associated with the potential presence of the B. cepacia pathogen.
The recalled product
- Product
- Major CertaVite Liquid, 8 oz. (236 mL)
- Manufacturer
- The Harvard Drug Group
- Category
- Food — Dietary Supplement
- Affected units
- 61,262
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 CertaVite Liquid
- 8 oz. (236 mL)
- UPC Number:3 09045 02309 9
- 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.
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