Sodium Sulfacetamide Wash Recalled for Subpotency Issues
Monarch PCM, LLC is recalling Sodium Sulfacetamide 10% Wash due to subpotency, meaning some bottles contain insufficient active ingredient or preservative levels.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall involving subpotency—a manufacturing defect in potency assay rather than a contamination or safety hazard. No illnesses or injuries are reported. Class III recalls typically receive a score of 1 or 2; subpotency of a topical medication represents a moderate concern warranting patient notification and therapeutic review rather than a critical or severe hazard.
Plain-English summary
Monarch PCM, LLC is recalling Sodium Sulfacetamide, 10%, Wash manufactured in the U.S.A. for Exact-Rx, Inc., located in Melville, NY. The recall applies to two bottle sizes: 6 fl oz (177 mL) bottles with NDC 42808-103-06 and 12 fl oz (354.8 mL) bottles with NDC 42808-103-12.
The product has been recalled due to subpotency—some units tested failed to meet required standards for active ingredient assay and others failed preservative assay requirements. Affected lots are: 21FP1737 with expiration 05/2023 (6 fl oz bottles) and 21FP1738 with expiration 05/2023 (12 fl oz bottles).
The affected product was distributed to Ohio and Tennessee. Patients using this medication should consult their healthcare provider or pharmacist about whether their supply may be affected and what alternative products or batches are available.
This is a prescription-only product. The FDA and the manufacturer advise healthcare providers and pharmacies to check inventory against the recalled lot numbers and NDC codes.
The recalled product
- 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
- Manufacturer
- Monarch PCM, LLC
- Category
- Drug — Topical / Wash
- Hazard
- subpotency
- active-ingredient-deficiency
- preservative-deficiency
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lots: a) 21FP1737 Exp 05/2023
- b) 21FP1738 Exp 05/2023
Distribution
Distributed in 2 states:
- OH
- TN
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