FDA Recalls CITROMA Magnesium Citrate for Microbial Contamination
Vi-Jon, LLC is recalling CITROMA magnesium citrate oral laxative solution due to microbial contamination. The affected product was distributed nationwide in the USA, Canada, and Panama.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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: FDA Class I classification indicates serious health risk. Microbial contamination in an oral drug product poses a significant risk of infection or illness. No reported illnesses have been documented in the source text.
Plain-English summary
CITROMA (magnesium citrate) oral solution is being recalled due to microbial contamination. The affected product is EQUALINE magnesium citrate saline laxative, 10 FL OZ (296 mL) bottles with dye-free lemon flavor, manufactured by Vi-Jon, LLC.
The affected lot is 0511629, expiring 12/4/2022. Approximately 5,304 bottles were distributed nationwide in the United States, Canada, and Panama.
Consumers who have this product should stop using it immediately and dispose of it safely. Anyone who has consumed this product and has health concerns should contact their healthcare provider.
The recalled product
- Product
- CITROMA (MAGNESIUM CITRATE)
- Brand
- CITROMA
- Manufacturer
- Vi-Jon, LLC
- Category
- Drug — Laxative
- Hazard
- Affected units
- 5,304
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 # 0511629
- EXP 12/4/2022
UPCs (1)
- 041163500686
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Vi-Jon, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
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