Laxative Product Recalled Over Contamination Concerns

Potential microbial contamination has prompted Vi-Jon LLC to recall a slate of branded magnesium citrate saline laxative products, many of which are under a Class I recall, according to the September 21, 2022, US Food and Drug Administration (FDA) Enforcement Report. A Class I designation warns that use of affected products could cause serious adverse health consequences or death.

The following products, which were distributed in the United States, Canada, and Panama, are included in the Class I recall:

• CVS Health magnesium citrate saline laxative oral solution (1.745 g/fl oz), lemon flavor, 10 fl oz (UPC 0 50428 30594 2, UPC 0 50428 33517 8), from lots 0556808 (Exp. 12/8/23), 0563095 (Exp. 2/18/24), 0562243 (Exp. 2/17/24), 0557622 (Exp. 1/12/24), and 0498395 (Exp. 8/8/22); distributed by CVS Pharmacy Inc;
• Equate magnesium citrate saline laxative (1.745g/fl oz), grape flavor, 10 fl oz (NDC 49035-592-38, UPC 6 81131 28715 9), from lot 0525509 (Exp. 3/6/23); distributed by Walmart;
• Equaline magnesium citrate saline laxative oral solution (1.745 g/fl oz), dye free, lemon flavor, 10 fl oz (NDC 41163-769-38, UPC 0 41163 50068 6), from lot 0511629 (Exp. 12/4/22); distributed by Supervalu;
• Kroger magnesium citrate saline laxative oral solution 1.745 g, lemon flavor, 10 fl oz (NDC 30142-899-38, UPC 0 41260 00182 6), from lot 0557622 (Exp. 1/12/24); distributed by Kroger;
• P magnesium citrate saline laxative oral solution (1.745 g/fl oz), lemon flavor, 10 fl oz (NDC 56062-266-38, UPC 0 41415 50673 2), from lot 0562243 (Exp. 2/17/24); distributed by Publix Super Markets;
• Rexall magnesium citrate saline laxative oral solution (1.745 g/fl oz), lemon flavor, 10 fl oz (NDC 55910-183-38, UPC 0 72785 13418 8), from lots 0511629 (Exp. 12/4/22) and 0562243 (Exp. 2/17/24); distributed by Dolgencorp or Old East Main Co;
• Swan Citroma magnesium citrate saline laxative oral solution (1.745 g/fl oz), lemony flavor, 10 fl oz (NDC 0869-0166-38, UPC 0 72785 13405 8), from lot 0562243 (Exp. 2/17/24); distributed by Vi-Jon;
• TopCare magnesium citrate saline laxative oral solution (1.745 g/fl oz), cherry flavor, 10 fl oz (NDC 36800-164-38, UPC 0 36800 45530 6), from lot 0546394 (Exp. 9/29/23); distributed by Topco Associates;
• Walgreens, dye-free, magnesium citrate saline laxative oral solution (1.745 g/fl oz), lemon flavor, 10 fl oz (NDC 0363-8166-38, UPC 3 11917 20160 3, green label), from lot 0505266 (Exp. 10/17/22); distributed by Walgreen Co; and
• Walgreens, dye-free, magnesium citrate saline laxative oral solution (1.745 g/fl oz), grape flavor, 10 fl oz (NDC 0363-7162-38, UPC 3 11917 20159 7, purple label), from lot 0506255 (Exp. 10/24/22); distributed by Walgreen Co.

Additionally, Vi-Jon recalled all remaining lots within expiry of magnesium citrate saline laxative oral solution, 1.745 g, 10 fl oz., in lemon, cherry, and grape flavors. The FDA designated those recalls Class II recall, which communicates use of the products may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm. The recall stems from deviations from Current Good Manufacturing Practices, according to the enforcement report.

The following brands of magnesium citrate saline laxative oral solution, 1.745 g, 10 fl oz., are affected by the Class II recall:

• Lemon flavor: CVS Health (UPC 0 50428 33517 8 or UPC 0 50428 30594 2), Best Choice (UPC 0 70038 20049 9), Care One (UPC 3 41520 31322 6), Cariba (UPC 6 46702 05701 2), Cruz Blanca (UPC 3 0869-7403-08 2, UPC 3 08697 40308 2), Discount Drug Mart (UPC 0 93351 02820 5), Equaline (NDC 41163-709-38, UPC 0 41163 50067 9), Equate (NDC 49035-506-38, UPC 6 81131 28714 2), Exchange Select (6 14299 40420 5), Family Wellness (UPC 0 32251 58082 6), Good Sense (NDC 50804-166-38, UPC 8 46036 00737 4), Harris Teeter (UPC 0 72036 72612 4), HEB (UPC 0 41220 51086 3), Health Mart (NDC 62011-0380-1, UPC 0 52569 14215 8), Kroger (NDC 30142-899-38, UPC 0 41260 00182 6), Leader sugar-free (NDC 70000-0424-1, UPC 0 96295 13554 1), Major (NDC 0904-6787-44, UPC 3 09046 78744 0), Meijer (NDC 41250-708-38, UPC 7 13733 45945 7), Premier Value (UPC 8 40986 03530 2), Publix (NDC 56062-266-38, UPC 0 41415 50673 2), Quality Choice (UPC 6 35515 90125 4), Rexall (UPC 0 72785 13418 8), Rite Aid (NDC 11822-4330-2, UPC 0 11822 43300 6), Signature Care (NDC 21130-709-38, UPC 3 21130 77915 5), Sound Body (UPC 0 72785 11479 1), Sunmark (NDC 70677-0051-1, UPC 0 10939 90844 5), Swan (NDC 0869-0166-38, UPC 0 72785 13405 8), TopCare (UPC 0 36800 45529 0), Up & Up (NDC 11673-708-38, NDC 11673-666-38, UPC 0 72785 12883 5), and Walgreens (NDC 0363-8166-38, UPC 3 11917 20160 3);
• Cherry flavor: Best Choice (UPC 0 70038 58790 3), CareOne (UPC 3 41520 00055 3), CareOne (UPC 3 41520 00055 3), CVS Health (UPC 0 50428 29733 9, UPC 0 50428 28515 2), Equaline (NDC 41163-769-38, UPC 0 41163 50068 6), Equate (NDC 49035-593-38, UPC 6 81131 28716 6), Family Wellness (NDC 56319-164-38, UPC 0 32251 57788 8), GoodSense (NDC 50804-164-38, UPC 8 46036 00739 8), HEB (UPC 0 41220 51087 0), Health Mart (NDC 62011-0381-1, UPC 0 52569 14216 5), Leader sugar-free (NDC 70000-0575-1, UPC 0 96295 14106 1, NDC 70000-0576-1, UPC 0 96295 14105), Meijer sugar free, low sodium (NDC 41250-769-38, UPC 7 13733 45944 0), Premier Value (UPC 8 40986 03529 6),) P/Publix (NDC 56062-264-38, UPC 0 41415 50573 5), Quality Choice (UPC 6 35515 90111 7), Rexall (UPC 0 72785 13416 4), Rite Aid (NDC 11822-4303-2, UPC 0 11822 43303 7), Signature Care (NDC 21130-165-38, UPC 3 21130 78971 0), Sunmark (NDC 70677-0053-1, UPC 0 10939 91044 8), Swan very low sodium (NDC 0869-0164-38, UPC 3 08690 69338 1), TopCare Health (NDC 36800-164-38, UPC 0 36800 45530 6), and Walgreens (NDC 0363-8164-38, UPC 3 11917 20158 0); and
• Grape flavor: Best Choice (UPC 0 70038 66220 4), CVS Health (UPC 0 50428 30745 8), Equate (NDC 49035-592-38, UPC 6 81131 28715 9), HEB (UPC 0 41220 51088 7), Kroger (UPC 0 41260 00871 9), Leader (NDC 70000-0576-1, UPC 0 96295 14105 4), Rexall (UPC 0 72785 13417 1), and Walgreens (NDC 0363-7162-38, UPC 3 11917 20159 7).

Magnesium citrate saline laxative oral solution is used to treat occasional constipation.