Monarch PCM, LLC: Drug Recall
Recall #D-0817-2021 · 09/01/2021
Class III: Low Risk
Recall Details
- Recall Number
- D-0817-2021
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Monarch PCM, LLC
- Status
- Terminated
- Date Initiated
- 09/01/2021
- Location
- Fort Worth, TX, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 3305 bottles; b) 840 bottles
Reason for Recall
Subpotency: one product for active ingredient assay and another one for preservative assay
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
Distribution Pattern
OH, TN
Other Recalls by Monarch PCM, LLC
- Class III: Low Risk 04/14/2022
- Class II: Risk 09/23/2021
- Class III: Low Risk 09/01/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.