Sodium Sulfacetamide recall
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
Why was Sodium Sulfacetamide recalled?
Subpotency: one product for active ingredient assay and another one for preservative assay
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots: a) 21FP1737 Exp 05/2023; b) 21FP1738 Exp 05/2023
- 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
- Recalling firm
- Monarch PCM, LLC
- Quantity
- a) 3305 bottles; b) 840 bottles
- Distribution
- OH, TN
- Recall date
- September 29, 2021
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)