Class III Recall

Monarch PCM, LLC

Product
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
Reason
Subpotency: one product for active ingredient assay and another one for preservative assay
Classification
Class III
Status
Terminated
Lot
Lots: a) 21FP1737 Exp 05/2023; b) 21FP1738 Exp 05/2023
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Monarch PCM, LLC — Class III Recall | MedicineWatch US