Reported Sep 14, 2022 · Terminated
Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups…
Plastikon Healthcare LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Plastikon Healthcare LLC · 3780 Greenway Cir · Lawrence, KS · 66046-5440
Is this the product you have?
Magnesium Hydroxide 1200 mgAluminum Hydroxide 1200 mgSimethicone 120 mg per 30 mL30 mL cuppackaged in 10 cups per tray10 trays per cartonFor Institutional Use OnlyMajor Pharmaceuticals17177 N Laurel Park DrSuite 233LivoniaMI 48152NDC 0904-6838-73
- Lot codes and dates
Lot # 20077A20080A20082AEXP Aug. 202221016AEXP Feb. 202321026AEXP Mar. 202321042A21047A21050AEXP Apr. 202321057A21059A21060AEXP May. 202321061A21067A21070A21072AEXP Jun. 202321095A21097A21099AEXP Sep. 202321107A21109A21111A21113AEXP Oct. 202321138AEXP Dec. 202322002A22004A22005AEXP Jan. 2024
- Amount recalled
- 521,700 cups
This recall covers 19 products
The agency filed one notice per product. You are reading one of them; the other 18 are below.
6 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
This product could cause temporary or reversible health problems — stop using it.
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