Products Affected - Description

• • Magnesium citrate oral solution, Vi-Jon, 1.745 gm/30 mL, 10 ounce bottle, Product : most brands

Reason for the Shortage

• • On June 21, 2022, Vi-Jon recalled one lot of CVS magnesium citrate lemon flavored oral solution due to contamination with Gluconacetobacter liquefaciens. On July 25, 2022, the recall was expanded to include all flavors and lots of magnesium citrate oral solution. Additional information including the complete list of affected products can be found at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vi-jon-llc-expands-voluntary-nationwide-recall-all-flavors-and-lots-within-expiry-magnesium-citrate?utm_medium=email&utm_source=govdelivery.
  • Vi-Jon is a key supplier of magnesium citrate oral solution.
  • Akron Pharma has magnesium citrate oral solution available. The company has a different source for magnesium citrate.
  • Bionpharma has magnesium citrate oral solution and Good Neighbor Pharmacy magnesium citrate oral solution available.

Available Products

• • Good Neighbor Pharmacy magnesium citrate oral solution, Bionpharma, 1.745 gm/30 mL, 10 ounce lemon flavor, bottle, NDC 46122-0740-38
  • Good Neighbor Pharmacy magnesium citrate oral solution, Bionpharma, 1.745 gm/30 mL, 10 ounce cherry flavor, bottle, NDC 46122-0741-38
  • OneLax oral solution, Akron Pharma, 1.745 gm/30 mL, 10 ounce bottle, NDC 71399-0051-01
  • Magnesium citrate oral solution, Bionpharma, 1.745 gm/30 mL, 10 ounce cherry flavor, bottle, NDC 69452-0390-98
  • Magnesium citrate oral solution, Bionpharma, 1.745 gm/30 mL, 10 ounce lemon flavor, bottle, NDC 69452-0389-98

• • Most magnesium citrate saline laxative oral solution 10 ounce bottles are unavailable and the distributing companies cannot estimate when additional product will be available.

• • Oral magnesium citrate is commonly used as a component of bowel preparations prior to colonoscopy and as a laxative. Guidelines from the American Society for Gastrointestinal Endoscopy (ASGE) do not recommend oral magnesium citrate as part of a bowel preparation due to limited efficacy and potential toxicity. Oral magnesium citrate is also used as a laxative. ASGE Guidelines can be found at https://www.giejournal.org/action/showPdf?pii=S0016-5107%2814%2902268-8
  • If additional bowel preparation is required beyond the usual polyethylene glycol (Miralax) and bisacodyl that are recommended for most patients, prescription oral sodium sulfate (Suprep) or oral sodium sulfate with PEG-ELS (Suclear) may be useful. Use alternative laxatives such as milk of magnesia or lactulose if oral magnesium is being used only as a laxative vs. bowel preparation. Milk of magnesia is not a good alternative for use as a bowel preparation because it is opaque and not clear.