SWAN, Citroma MAGNESIUM CITRATE, Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemony Flavor, 10 FL OZ (296 mL), Dist
Summary
The FDA issued a Class I for SWAN, Citroma MAGNESIUM CITRATE, Saline Laxative, Oral Solution, (1.745 g/fl oz) by Vi-Jon, LLC. Reason: Microbial contamination of non-sterile products..
Details
Source
Drug Recall
External ID
D-1507-2022
Action Date
2022-09-21
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot # 0562243, EXP 2/17/2024
Quantity Affected: 27,612 bottles
Reason for Recall
Microbial contamination of non-sterile products.
Distribution
Distributed Nationwide in the USA as well as Canada and Panama.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-15
Company
Smyrna, TN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 76 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Vi-Jon, LLC has 20 FDA actions in our database, including 20 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Vi-Jon, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Vi-Jon, LLC have FDA actions?
Vi-Jon, LLC has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1507-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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