MINISTRY OF HEALTH AND HUMAN SERVICES ADVISES OF DRUG RECALL

Providenciales, August 2, 2022)…..Ministry of Health and Human Services (MoHHS) issues voluntary recall of Vi-Jon LLC’s Magnesium Citrate Saline Laxative Oral Solution due to microbial contamination.

The Ministry of Health and Human Services (MoHHS), in response to a U.S. Food and Drug Administration (FDA) advisory, is advising all local suppliers and the general public to discontinue the sale and/or use of all flavours of Magnesium Citrate Saline Laxative Oral Solution 10 FL Oz (296ml) (Cherry, Grape and Lemon Flavours) products distributed by Vi-Jon LLC’s in the United States (see below). The product is used for the relief of occasional constipation and is packaged in clear round plastic bottles.

The advisory results from an expanded voluntary recall that was initiated after microbial testing identified the presence of the bacteria Gluconacetobacter liquefaciens in these products. The previous voluntary recall concerned one (1) lot of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavour 10 FL Oz (296 ml). The affected CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavour lot includes the following batch number: 0556808 and expiration date: 12/2023 on the shoulder of the bottle. The other affected brands are listed below.

Vi-Jon LLC has issued a risk statement which indicates that immunocompromised patients may be at increased risk for infections – caused by Gluconacetobacter liquefaciens – that tend to spread in an especially quick and aggressive manner leading to serious, life-threatening adverse health consequences.  Of note, Vi-Jon LLC has also received three (3) reports of an adverse reaction potentially related to this recall. The company is in the process of investigating these reports. Notably, further updates will be provided as investigations continue.

The MoHHS therefore implores all local suppliers to:

1. Immediately stop supplying the affected lots of the brands listed above.
2. Notify your overseas vendors.
3. Quarantine all remaining stock(s) of the identified brands for possible disposal by the Environmental Health Department.

Additionally, the MoHHS wishes to advise consumers to stop using the affected products and contact their respective pharmacies or other local suppliers. Consumers may contact the Environmental Health Department at 338-2142 for more information on how best to dispose of these products. In addition, consumers should contact their physician or healthcare provider if they have any questions, concerns or have experienced any problems related to the use of antacid products. Consumers are also advised to report any side effects via the MoHHS’ Adverse Drug Reaction Form found at https://gov.tc/docs/ADR.pdf.

The MoHHS’ top priority is to ensure public health safety and will therefore continue to monitor this situation as investigations continue.

For further information, please contact the MoHHS at 338-3072.