FDA Reports Recall of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination
On June 21, 2022, the U.S. Food and Drug Administration (FDA) reported (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vi-jon-llc-issues-voluntary-nationwide-recall-cvs-magnesium-citrate-saline-laxative-oral-solution?utm_medium=email&utm_source=govdelivery) Vi-Jon, LLC’s, voluntarily recall of one lot of CVS magnesium citrate saline laxative oral solution lemon flavor, 10 fl oz (296 ml), after testing revealed the product contains the bacteria Gluconacetobacter liquefaciens.
In the recall, Vi-Jon, LLC, advised that immunocompromised patients who consume this product may be at increased risk for infections that could lead to life-threatening adverse health consequences. To date, Vi-Jon, LLC, has not reported any complaints related to the recall.
The affected lot’s batch number is 0556808 and has the expiration date of 12/2023, both of which are printed on the bottle’s shoulder. The recalled lot was distributed to CVS drug stores nationwide.
On July 14, 2022, FDA reported (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vi-jon-llc-expands-voluntary-nationwide-recall-magnesium-citrate-saline-laxative-oral-solution-lemon?utm_medium=email&utm_source=govdelivery) that Vi-Jon, LLC, expanded the recall to include all lots of the product at the consumer level. The following products are now included:
|
Affected Brand |
NDC |
UPC |
|
Best Choice 10 oz lemon magnesium citrate |
63941-533-38 |
070038200499 |
|
Care One 10 oz lemon magnesium citrate |
72476-001-38 |
341520313226 |
|
Cariba 10 oz lemon magnesium citrate |
67860-166-38 |
646702057012 |
|
Cruz Blanc 10 oz lemon magnesium citrate |
N/A |
308697403082 |
|
CVS 10 oz lemon magnesium citrate |
63868-929-38 |
050428335178 |
|
CVS 10 oz lemon magnesium citrate |
69842-983-38 |
050428305942 |
|
Discount Drug Mart 10 oz lemon magnesium citrate |
53943-166-38 |
093351028205 |
|
Equaline 10 oz lemon magnesium citrate |
41163-709-38 |
041163500679 |
|
Equate 10 oz lemon magnesium citrate syrup |
49035-506-38 |
681131287142 |
|
Exchange Select 10 oz lemon magnesium citrate |
55301-166-38 |
614299404205 |
|
Family Wellness 10 oz lemon citrate |
55319-666-38 |
032251580826 |
|
Good Sense 10 oz lemon magnesium citrate |
50804-166-38 |
846036007374 |
|
Harris Teeter 10 oz lemon magnesium citrate |
72036-002-38 |
072036726124 |
|
Heb 10 oz lemon magnesium citrate |
37808-769-38 |
041220510863 |
|
Health Mart 10 oz lemon magnesium citrate |
62011-0380-1 |
052569142158 |
|
Kroger 10 oz lemon magnesium citrate |
30142-899-38 |
041260001826 |
|
Leader 10 oz lemon magnesium citrate |
70000-0424-1 |
096295135541 |
|
Major 10 oz lemon magnesium citrate |
0904-6787-44 |
309046787440 |
|
Meijer 10 oz lemon magnesium citrate |
41250-708-38 |
713733459457 |
|
Premier Value 10 oz low sodium lemon citrate |
68016-696-38 |
840986035302 |
|
Publix 10 oz lemon magnesium citrate |
56062-266-38 |
041415506732 |
|
Quality Choice 10 oz lemon magnesium citrate |
63868-929-38 |
635515901254 |
|
Rexall 10 oz lemon magnesium citrate |
55910-183-38 |
072785134188 |
|
Rite Aid 10 oz lemon citrate |
11822-4330-2 |
011822433006 |
|
Signature Care 10 oz lemon magnesium citrate |
21130-709-38 |
321130779155 |
|
Sound Body 10 oz lemon magnesium citrate |
50594-166-38 |
072785114791 |
|
Sunmark 10 oz lemon magnesium citrate |
70677-0051-1 |
010939908445 |
|
Swan 10 oz lemon magnesium citrate |
0869-0166-38 |
072785134058 |
|
Topcare 10 oz lemon magnesium citrate |
36800-709-38 |
036800455290 |
|
Up&Up 10 oz lemon magnesium citrate |
11673-708-38 |
072785128835 |
|
Up&Up 10 oz lemon magnesium citrate |
11673-666-38 |
072785128835 |
|
Walgreens 10 oz lemon magnesium citrate |
0363-8166-38 |
311917201603 |
NDC—national drug code; UPC—universal product code
On July 26, 2022, FDA reported (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) that Vi-Jon, LLC, expanded the recall to include all lots of all flavors the product at the consumer level. The following products are now included:
|
Affected Brand |
NDC |
UPC |
|
Best Choice 10 oz cherry citrate |
63941-516-38 |
070038587903 |
|
Best Choice 10 oz grape citrate |
63941-162-38 |
070038662204 |
|
Care One 10 oz cherry citrate |
72476-002-38 |
341520000553 |
|
CVS 10 oz cherry citrate |
69842-647-38 |
050428297339 |
|
CVS 10 oz cherry citrate |
69842-647-38 |
00050428285152 |
|
CVS 10 oz clear grape citrate |
69842-763-38 |
050428307458 |
|
CVS 10 oz clear grape citrate |
69842-763-38 |
00050428325032 |
|
Equaline 10 oz cherry citrate |
41163-769-38 |
041163500686 |
|
Equate 10 oz cherry citrate syrup |
49035-593-38 |
681131287166 |
|
Equate 10 oz grape magnesium citrate syrup |
49035-592-38 |
681131287159 |
|
Family Wellness 10 oz cherry citrate |
55319-164-38 |
032251577888 |
|
Good Sense 10 oz cherry citrate |
50804-164-38 |
846036007398 |
|
Heb 10 oz cherry citrate |
37808-673-38 |
00041220510870 |
|
Heb 10 oz grape magnesium citrate |
37808-695-38 |
00041220510887 |
|
Health Mart 10 oz cherry citrate |
62011-0381-1 |
052569142165 |
|
Kroger 10 oz grape citrate |
30142-806-38 |
041260008719 |
|
Leader 10 oz cherry citrate |
70000-0575-1 |
096295141061 |
|
Leader 10 oz grape magnesium citrate |
70000-0576-1 |
096295141054 |
|
Meijer 10 oz cherry citrate |
41250-769-38 |
713733459440 |
|
Premier Value 10 oz cherry citrate |
68016-701-38 |
840986035296 |
|
Publix 10 oz cherry citrate |
56062-264-38 |
041415505735 |
|
Quality Choice 10oz cherry citrate |
63868-018-38 |
635515901117 |
|
Rexall 10 oz cherry citrate |
55910-961-38 |
072785134164 |
|
Rexall 10 oz grape magnesium citrate |
55910-615-38 |
072785134171 |
|
Rite Aid 10 oz cherry citrate |
11822-4303-2 |
011822433037 |
|
Signature Care 10 oz cherry citrate |
21130-165-38 |
321130789710 |
|
Sunmark 10 oz cherry citrate |
70677-0053-1 |
010939910448 |
|
Swan 10 oz cherry citrate |
0869-0164-38 |
308690693381 |
|
Topcare 10 oz cherry citrate |
36800-164-38 |
036800455306 |
|
Walgreens 10 oz cherry citrate |
0363-8164-38 |
311917201580 |
|
Walgreens 10 oz grape mag citrate |
0363-7162-38 |
311917201597 |
NDC—national drug code; UPC—universal product code
The product was distributed to wholesale and retail outlets nationwide. Vi-Jon, LLC, is investigating three reports of serious adverse reactions potentially related to the recall.
FDA reported that Vi-Jon, LLC, notified customers by phone and email and is arranging for return of all recalled product. Consumers and healthcare providers should stop using any of the affected lots and return any remaining product.
Patients and consumers with questions regarding the recall can contact Vi-Jon, LLC, at Recalls@Vijon.com (mailto:Recalls@Vijon.com) Monday–Friday, from 7:30 am–4:30 pm CST. Consumers should contact their healthcare provider if they experience any health problems potentially related to the product.
Healthcare professionals and consumers should report any adverse reactions or quality problems (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.