D-0817-2021 Class III Terminated
FDA drug recall D-0817-2021 was initiated by Monarch PCM, LLC on Sep 1, 2021 and is designated Class III. Reason for recall: Subpotency: one product for active ingredient assay and another one for preservative assay The recall status is terminated (terminated Jun 21, 2023). Affected quantity: a) 3305 bottles; b) 840 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 29, 2021
- Initiation Date
- Sep 1, 2021
- Termination Date
- Jun 21, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 3305 bottles; b) 840 bottles
Product Description
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 for Recall
Subpotency: one product for active ingredient assay and another one for preservative assay
Distribution Pattern
OH, TN
Code Information
Lots: a) 21FP1737 Exp 05/2023; b) 21FP1738 Exp 05/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0817-2021
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026