FDA recall D-0817-2021

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 for recall

Subpotency: one product for active ingredient assay and another one for preservative assay

Distribution

OH, TN

Key facts

Status

Terminated

Initiation date

2021-09-01

Report date

2021-09-29

Termination date

2023-06-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fort Worth, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0817-2021