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
Reported: September 29, 2021 Initiated: September 1, 2021 #D-0817-2021
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
Details
- Recalling Firm
- Monarch PCM, LLC
- Units Affected
- a) 3305 bottles; b) 840 bottles
- Distribution
- OH, TN
- Location
- Fort Worth, TX
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Monarch PCM, LLC. Units affected: a) 3305 bottles; b) 840 bottles.
Why was this product recalled? ▼
Subpotency: one product for active ingredient assay and another one for preservative assay
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 29, 2021. Severity: Low. Recall number: D-0817-2021.
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