Plastikon Healthcare recalls specific lots of 10mL cough syrup cups due to manufacturing process deviations that may affect product quality. Affected products were sold for institutional use only.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Plastikon Healthcare is recalling certain lots of cough syrup cups because they were made under manufacturing conditions that weren't properly controlled. This could mean the product might not be safe for use as intended.
The recall is due to CGMP (Current Good Manufacturing Practices) deviations during production. This means the manufacturing process wasn't controlled properly, which could lead to product quality issues. However, the specific risks aren't clearly described in the recall notice.
Institutional users who purchased the specific lots of cough syrup cups with the listed lot numbers and expiration dates are affected. People using these products for medical purposes should check if they have the recalled items.
Check for the product name 'Guaifenesin and Dextromethorphan 200-20 mg/10 mL' in 10 mL cups packaged in 10 per tray and 10 trays per carton. Look for the lot numbers listed in the recall: 20091A through 22016B with their specific expiration dates.
Identify the lot number and expiration date on the product packaging to determine if it's in the recalled list.
The recall is due to CGMP deviations during manufacturing, meaning the production process wasn't controlled properly. The exact risks aren't specified in the notice.
Check for the specific lot numbers listed: 20091A through 22016B with their corresponding expiration dates. The product is for institutional use only.
The recall notice doesn't specify a remedy, so you should check the product details to see if it's in the recalled list and contact the manufacturer if unsure.
We’ve drafted a message you can send Plastikon Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-1491-2022 — Plastikon Healthcare Plastikon Healthcare Hello, I own a Plastikon Healthcare that is covered by recall D-1491-2022 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.
