Drug 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
D-0817-2021
Product summary
- Firm
- Monarch PCM, LLC
- Event
- Event 88598
- Status
- Terminated
- Classification
- Class III
- Quantity
- a) 3305 bottles; b) 840 bottles
- Official record key
drug-enforcement:D-0817-2021
Official wording
Reason: Subpotency: one product for active ingredient assay and another one for preservative assay
Code information: Lots: a) 21FP1737 Exp 05/2023; b) 21FP1738 Exp 05/2023
Distribution pattern: OH, TN
Derived failure modes
-
Potency or specification failure
Subpotency