Microbial Contamination Prompts Class I Recall

Microbial contamination has prompted Plastikon Healthcare to recall numerous lots of Milk of Magnesia and magnesium hydroxide/aluminum hydroxide/simethicone oral suspension, according to the September 14, 2022, US Food and Drug Administration (FDA) Enforcement Report. The FDA has designated portions of the recall Class I, which warns use of the affected products could cause serious adverse health consequences or death.

The Class I recall affects the following products, which were distributed nationwide:

• Milk of Magnesia, 2400 mg/10 mL, magnesium hydroxide, 30-mL cup, packaged 10 cups per tray, 10 trays per carton (NDC 0904-6840-72), for institutional use only, Major Pharmaceuticals, from lot 20074A (Exp. 7/22);
• Milk of Magnesia, 2400 mg/30 mL, magnesium hydroxide, 30-mL cup, packaged 10 cups per tray, 10 trays per carton (NDC 0904-6846-73), for institutional use only, Major Pharmaceuticals, from lot 20071A (Exp. 7/22);
• magnesium hydroxide 1200 mg, aluminum hydroxide 1200 mg, simethicone 120 mg per 30 mL, 30-mL cup, packaged 10 cups per tray, 10 trays per carton (NDC 0904-6838-73), for institutional use only, Major Pharmaceuticals, from lots 20076A (Exp. 7/22), 20079A and 20081A (Exp. 8/22), 21096A (Exp. 10/22), and 21115A and 21103A (Exp. 9/22); and
• magnesium hydroxide 2400 mg, aluminum hydroxide 2400 mg, simethicone 240 mg MAX per 30 mL oral suspension, 30-mL cup, packaged 10 cups per tray, 10 trays per carton (NDC 0904-6839-73), for institutional use only, Major Pharmaceuticals, from lots 20051A (Exp. 8/22) and 20088A (Exp. 9/22).

Additional products are also under recall from Plastikon Healthcare because they were manufactured under inadequately controlled conditions. The FDA designated the following recalls Class II, communicating use of the products may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm:

• Milk of Magnesia, 2400 mg/10 mL, magnesium hydroxide, 30-mL cup, packaged 10 cups per tray, 10 trays per carton (NDC 0904-6840-72), for institutional use only, Major Pharmaceuticals, from lots 20085A (Exp. 8/22), 20099A (Exp. 10/22), 21039A and 21052A (Exp. 5/23), 21114A (Exp. 10/23), and 21130A and 21132A (Exp. 12/23);
• Milk of Magnesia, 2400 mg/30 mL, magnesium hydroxide, 30-mL cup, packaged 10 cups per tray, 10 trays per carton (NDC 0904-6846-73), for institutional use only, Major Pharmaceuticals, from lots 20072A and 20075A (Exp. 7/22), 20087A (Exp. 8/22), 20089A and 20090A (Exp. 9/22), 20100A and 20102A (Exp. 10/22), 20106A and 20107A (Exp. 11/22), 20109A (Exp.  12/22), 21010A (Exp. 1/23), 21028A, 21030A, and 21032A (Exp. 3/23), 21045A and 21046A (Exp. 4/23), 21054A (Exp. 5/23), 21078A, 21079A, and 21085A (Exp. 7/23), and 21088A (Exp.  8/23);
• magnesium hydroxide 1200 mg, aluminum hydroxide 1200 mg, simethicone 120 mg per 30 mL, 30-mL cup, packaged 10 cups per tray, 10 trays per carton (NDC 0904-6838-73), for institutional use only, Major Pharmaceuticals, from lots 20077A, 20080A, and 20082A (Exp. 8/22), 21016A (Exp. 2/23), 21026A (Exp. 3/23), 21042A, 21047A, and 21050A (Exp. 4/23), 21057A, 21059A, and 21060A (Exp. 5/23), 21061A, 21067A, 21070A, and 21072A (Exp. 6/23), 21095A, 21097A, and 21099A (Exp. 9/23), 21107A, 21109A, 21111A, and 21113A (Exp. 10/23), 21138A (Exp. 12/23), and 22002A, 22004A, and 22005A (Exp. 1/24); and
• magnesium hydroxide 2400 mg, aluminum hydroxide 2400 mg, simethicone 240 mg MAX, per 30 mL oral suspension, 30-mL cup, packaged 10 cups per tray, 10 trays per carton (NDC 0904-6839-73), for institutional use only, Major Pharmaceuticals, from lots 20084A and 20086A (Exp. 8/22), and 21074A and 21077A (Exp. 7/23).

Plastikon Healthcare voluntarily initiated the recall June 7, 2022. The FDA issued its recall designations on September 6, 2022.

Milk of Magnesia is indicated for the occasional relief of constipation in adults and children 12 years and older or for children under 12 as recommended by a doctor. Magnesium hydroxide/ aluminum hydroxide, simethicone is indicated for the relief of acid indigestion, heartburn, sour stomach, and upset stomach.