D-0817-2021 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 29, 2021
- Initiation Date
- September 1, 2021
- Termination Date
- June 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