🔍 RecallPedia

Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5; b) 12 fl oz (354.8 mL) NDC 42808-103-12 UPC 3 42808 10312 6, Rx only, Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

Class I - Dangerous
💊 Drugs Recalled: September 1, 2021 Monarch PCM Prescription Drugs

What Should You Do?

  1. Check if you have this product:
    Lots: a) 21FP1737 Exp 05/2023; b) 21FP1738 Exp 05/2023
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Monarch PCM, LLC
Reason for Recall:
Subpotency: one product for active ingredient assay and another one for preservative assay
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5; b) 12 fl oz (354.8 mL) NDC 42808-103-12 UPC 3 42808 10312 6, Rx only, Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

Product Codes/Lot Numbers:

Lots: a) 21FP1737 Exp 05/2023; b) 21FP1738 Exp 05/2023

Distribution:

Distributed in: OH, TN

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0817-2021

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