Monarch PCM recalls specific Sodium Sulfacetamide 10% wash bottles with subpotency issues. Products may not contain enough active ingredient or preservative. Contact for return instructions.
Subpotency: one product for active ingredient assay and another one for preservative assay
Monarch PCM is recalling two sizes of Sodium Sulfacetamide 10% wash products due to subpotency. This means some bottles may not contain the correct amount of active ingredient or preservative, potentially affecting effectiveness.
The recall is for subpotency, meaning the product may not contain enough active ingredient or preservative as tested. This could lead to reduced effectiveness of the wash product, especially for medical use.
People who own or use the recalled Sodium Sulfacetamide 10% wash products. Those with medical conditions requiring precise medication dosing may be at higher risk.
Check for bottles labeled 6 fl oz (177 mL) NDC 42808-103-06 or 12 fl oz (354.8 mL) NDC 42808-103-12 with expiration dates May 2023.
Look for the product's NDC number and expiration date on the bottle to confirm if it's recalled.
The product may have subpotency, meaning it might not contain enough active ingredient or preservative. It is not recommended for use until the recall remedy is followed.
Check for bottles labeled 6 fl oz (177 mL) NDC 42808-103-06 or 12 fl oz (354.8 mL) NDC 42808-103-12 with expiration dates May 2023.
The recall remedy is not specified in the record, so contact Monarch PCM for instructions.
We’ve drafted a message you can send Monarch PCM to request your refund or repair — edit it as you like.
Subject: Recall D-0817-2021 — Monarch PCM Monarch PCM Hello, I own a Monarch PCM that is covered by recall D-0817-2021 from Monarch PCM. 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.
