Plastikon Healthcare recalls 10-tray magnesium hydroxide cups due to failed microbial testing. This institutional product may have unsafe bacteria levels. Consumers should contact the manufacturer for details.
CGMP Deviations: Failure to properly investigate failed microbial testing.
Plastikon Healthcare is recalling magnesium hydroxide and simethicone 30mL cups used in institutions because of microbial testing failures. This could mean unsafe bacteria levels in the product.
The product failed microbial testing, meaning bacteria could be present. This is a manufacturing issue that may not have been properly investigated.
Institutional users who purchased the 10-tray cups with specific lot numbers (20042A-20047A) from May 2022. These products are not for general consumer use.
Check for lot numbers 20042A, 20043A, 20045A, 20046A, or 20047A on the packaging. The product is labeled for institutional use only and comes in 10 cups per tray.
Look for lot numbers 20042A, 20043A, 20045A, 20046A, or 20047A on the packaging.
The product has failed microbial testing, so it may contain unsafe bacteria levels. Plastikon Healthcare recommends checking the lot number and contacting them for details.
Check for lot numbers 20042A, 20043A, 20045A, 20046A, or 20047A on the packaging. The product is labeled for institutional use only.
The recall does not specify a remedy. Contact Plastikon Healthcare directly for instructions.
We’ve drafted a message you can send Plastikon Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0871-2022 — Plastikon Healthcare Plastikon Healthcare Hello, I own a Plastikon Healthcare that is covered by recall D-0871-2022 from Plastikon Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
