FDA-Drug2021-09-29Class III
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
Monarch PCM, LLC
Hazard
Subpotency: one product for active ingredient assay and another one for preservative assay
Sold states
OH, TN
Affected count
a) 3305 bottles; b) 840 bottles
Manufactured in
7333 Jack Newell Blvd N Ste 100, Fort Worth, TX, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0817-2021Don't want to check this manually?
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