Plastikon Healthcare recalls calcium carbonate oral suspension due to CGMP deviations in manufacturing. Products with specific lot numbers and expiration dates are affected. Consumers should contact the manufacturer for details.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Plastikon Healthcare is recalling calcium carbonate oral suspension products that were manufactured under conditions with CGMP deviations. This means the products may not meet quality standards, though the recall does not specify a risk of injury or harm.
The products were manufactured under conditions that did not meet controlled manufacturing processes. This could result in the product not meeting quality standards, but the recall does not specify a risk of injury or harm.
Institutional users of calcium carbonate oral suspension, such as hospitals or clinics, are affected. Individuals using the product for medical purposes should check if their product is included in the recall.
Check for lot numbers 21021A, 21023A, 21024A, 21064A, 21073A, 21075A, 21100A, 21118A, 21120A, 21128A, 21129A, 21131A, 21135A, 22019A, and expiration dates through December 2023 or March 2024.
Identify the lot number and expiration date on the product packaging to determine if it is affected.
The recall states there were CGMP deviations in manufacturing, but does not specify a risk of injury or harm. The product may not meet quality standards.
Contact Plastikon Healthcare at 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152 for details on the recall and next steps.
Yes, affected lot numbers include 21021A, 21023A, 21024A, 21064A, 21073A, 21075A, 21100A, 21118A, 21120A, 21128A, 21129A, 21131A, 21135A, and 22019A.
We’ve drafted a message you can send Plastikon Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-1487-2022 — Plastikon Healthcare Plastikon Healthcare Hello, I own a Plastikon Healthcare that is covered by recall D-1487-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
