Delsam Pharma recalls artificial tears eye drops (10mg/1ml) due to CGMP deviations in manufacturing. Affected lots were produced in the same facility as contaminated batches. Consumers should check their bottle's lot number and expiration date.
CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
Delsam Pharma is recalling artificial tears eye drops that were manufactured in the same facility as contaminated batches. This recall is due to CGMP deviations, which means the product may not be safe for use.
The eye drops were manufactured in the same facility as batches found to be contaminated. CGMP deviations indicate potential quality control failures that could affect product safety, though the specific contamination is not detailed in the recall.
People who own or use Delsam Pharma's artificial tears eye drops with the lot numbers PCMH003, PCMH004, PCMH006, or PCMH008 (expired November 2023) are affected. Those with the product in the same facility as contaminated batches are at higher risk.
Check the bottle for the lot numbers PCMH003, PCMH004, PCMH006, or PCMH008. The product expires November 2023 and is labeled as 10 mg per 1 ml, 1% concentration.
Look for the lot number on the bottle label: PCMH003, PCMH004, PCMH006, or PCMH008.
The product was manufactured in the same facility as batches found to be contaminated, leading to CGMP deviations.
Check the lot number on the bottle. If it matches PCMH003, PCMH004, PCMH006, or PCMH008, stop using it and contact Delsam Pharma for instructions.
The recall indicates potential quality control issues, but the specific contamination is not detailed. Do not use if the lot number matches the affected batches.
We’ve drafted a message you can send Delsam Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0922-2023 — Delsam Pharma Delsam Pharma Hello, I own a Delsam Pharma that is covered by recall D-0922-2023 from Delsam Pharma. 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.
