FDA Reports Recall of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination

July 28, 2022

On June 21, 2022, the U.S. Food and Drug Administration (FDA) reported 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.

FDA Reports Recall of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination

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 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 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 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 they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.


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