Recalls / Class III
Class IIID-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
- Affected lot / code info
- Lots: a) 21FP1737 Exp 05/2023; b) 21FP1738 Exp 05/2023
Why it was recalled
Subpotency: one product for active ingredient assay and another one for preservative assay
Recalling firm
- Firm
- Monarch PCM, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 7333 Jack Newell Blvd N Ste 100, Fort Worth, Texas 76118-7151
Distribution
- Quantity
- a) 3305 bottles; b) 840 bottles
- Distribution pattern
- OH, TN
Timeline
- Recall initiated
- 2021-09-01
- FDA classified
- 2021-09-20
- Posted by FDA
- 2021-09-29
- Terminated
- 2023-06-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0817-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.