Reported Sep 29, 2021 · Terminated
Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5; b) 12…
Monarch PCM, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Monarch PCM, LLC · 7333 Jack Newell Blvd N Ste 100 · Fort Worth, TX · 76118-7151
Is this the product you have?
- Sodium Sulfacetamide, 10%, Wash
- packaged in bottlesa) 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
- Lot codes and dates
- Lots
a) 21FP1737 Exp 05/2023b) 21FP1738 Exp 05/2023
- Lots
- Amount recalled
- a) 3305 bottles; b) 840 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Subpotency: one product for active ingredient assay and another one for preservative assay
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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