The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-1507-2022·Announced 2022-09-21

SWAN Citroma Saline Laxative Recalled for Microbial Contamination

Vi-Jon is recalling SWAN Citroma Magnesium Citrate Saline Laxative (10 FL OZ bottles) due to microbial contamination of a non-sterile product. The 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 mandates a minimum severity rating of Severe (4). Although no illnesses or deaths are reported in the source, the Class I status reflects a serious health risk from microbial contamination.

Plain-English summary

Vi-Jon, LLC is recalling SWAN Citroma Magnesium Citrate Saline Laxative, an oral solution in 10 FL OZ (296 mL) bottles with Lemony Flavor at a strength of 1.745 g/fl oz. The affected product carries lot number 0562243 with an expiration date of 2/17/2024, NDC 0869-0166-38, and UPC 0 72785 13405 8. Approximately 27,612 bottles have been distributed.

The recall is due to microbial contamination of the non-sterile product. The affected product was distributed nationwide in the United States, as well as in Canada and Panama.

Consumers who have purchased this product should stop using it immediately and should not consume it. If you have the recalled product, verify the lot number (0562243) and expiration date (2/17/2024) on your bottle. Contact Vi-Jon, LLC or consult your healthcare provider with questions or concerns.

The recalled product

Product
SWAN, Citroma MAGNESIUM CITRATE, Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemony Flavor, 10 FL OZ (296 mL), Distributed by: Vi-Jon, Inc. One Swan Drive Smyrna, TN 37167; NDC 0869-0166-38 UPC 0 72785 13405 8
Manufacturer
Vi-Jon, LLC
Category
Drug — Laxative
Hazard
Affected units
27,612

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 # 0562243
  • EXP 2/17/2024

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 →

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