Plastikon Healthcare recalls diphenhydramine oral solution due to manufacturing control deviations. Products may not meet quality standards. Consumers should check lot numbers and contact the company for details.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Plastikon Healthcare is recalling diphenhydramine HCl oral solution for institutional use because of manufacturing control issues. This could mean the product does not meet quality standards, but the recall does not specify a risk of injury or harm to users.
The product was manufactured under conditions that did not meet controlled quality standards. This could mean the solution may not be safe or effective for use, but the recall does not state a specific risk of injury or harm.
Institutional users who purchased the diphenhydramine oral solution with lot numbers listed in the recall. The risk is not specified for individual users.
Check the lot numbers on the packaging: 20065A, 20068A, 20070A, 20097A, 20098A, 21055A, 21083A, 21091A, 21112A. The product is labeled for institutional use only and comes in 10 mL cups packaged in 10 cups per tray, 10 trays per carton.
Look for lot numbers on the packaging: 20065A, 20068A, 20070A, 20097A, 20098A, 21055A, 21083A, 21091A, 21112A.
The recall states there were manufacturing control deviations, but does not specify if the product is unsafe or harmful to users.
The recall does not provide specific action steps for consumers beyond checking the lot number.
Check the lot numbers on the packaging: 20065A, 20068A, 20070A, 20097A, 20098A, 21055A, 21083A, 21091A, 21112A.
We’ve drafted a message you can send Plastikon Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-1489-2022 — Plastikon Healthcare Plastikon Healthcare Hello, I own a Plastikon Healthcare that is covered by recall D-1489-2022 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.
