Akorn recalls 0.3% ofloxacin eye drops (5mL) due to manufacturing deviations. This may affect safety. Check NDC 13985-602-05 and lot numbers for affected products.
CGMP Deviations:
Akorn is recalling certain 0.3% ofloxacin eye drops (5mL) because of manufacturing deviations that could affect safety. This recall affects prescription-only products sold with specific lot numbers and expiration dates.
The recall is due to CGMP (current good manufacturing practice) deviations during production. These deviations could potentially affect the safety and quality of the medication, though the specific risk is not detailed in the notice.
Prescription patients who received the recalled eye drops with NDC 13985-602-05 and lot numbers 11B26A (expiring 1/31/2023) or 1H02A (expiring 7/31/2023). Patients using these products are most at risk.
Check the product label for NDC 13985-602-05 and lot numbers 11B26A (expiring 1/31/2023) or 1H02A (expiring 7/31/2023). The product is a prescription-only eye drop solution.
Look for NDC 13985-602-05 and lot numbers 11B26A (expiring 1/31/2023) or 1H02A (expiring 7/31/2023) on the bottle.
The recall states there were CGMP deviations, but the specific safety risk is not detailed. The product may not be safe, but the official notice does not specify the exact hazard.
Check the product label for NDC 13985-602-05 and lot numbers 11B26A (expiring 1/31/2023) or 1H02A (expiring 7/31/2023).
The recall does not specify a remedy, so the official notice does not state what action to take.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0146-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0146-2023 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.
