Akorn recalls 20 mg/2 mL dicyclomine hydrochloride injection ampules due to inability to conduct stability studies after firm went out of business.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling dicyclomine hydrochloride injection ampules because the manufacturer went out of business and can no longer perform stability testing. This means the product's safety and effectiveness cannot be confirmed.
The manufacturer went out of business and can no longer conduct stability studies to ensure the product remains safe and effective over time. Without this testing, there is uncertainty about whether the medication will maintain its intended properties.
Prescription drug users who have the recalled dicyclomine hydrochloride injection ampules. Patients at risk are those who have been prescribed this medication by a healthcare provider.
The product is dicyclomine hydrochloride injection ampules labeled 20 mg/2 mL (10 mg/mL), prescription-only, distributed by Akorn. All lots and all National Drug Codes (NDCs) are affected.
Review the product label for the 20 mg/2 mL (10 mg/mL) dicyclomine hydrochloride injection ampules.
The manufacturer went out of business and can no longer continue stability studies, making it impossible to confirm the product's safety and effectiveness.
The recall record does not specify a remedy, so no action is required beyond checking if you have the product.
The recall is due to stability concerns, not an immediate safety hazard. However, the product's effectiveness cannot be confirmed without stability testing.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0799-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0799-2023 from Akorn. 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.
