Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lots: a) 21FP1737 Exp 05/2023; b) 21FP1738 Exp 05/2023
Where it was sold
OH, TN
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0817-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 1, 2021
- FDA report date
- Sep 29, 2021
- Quantity
- a) 3305 bottles; b) 840 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Monarch PCM, LLC
Original FDA data
Every field from FDA enforcement report D-0817-2021, exactly as published.
Show all FDA fields
- City
- Fort Worth
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 88598
- Address
- 7333 Jack Newell Blvd N Ste 100
- Code information
- Lots: a) 21FP1737 Exp 05/2023; b) 21FP1738 Exp 05/2023
- Postal code
- 76118-7151
- Report date
- Sep 29, 2021
- Product type
- Drugs
- Recall number
- D-0817-2021
- Classification
- Class III
- Recalling firm
- Monarch PCM, LLC
- Product quantity
- a) 3305 bottles; b) 840 bottles
- Termination date
- Jun 21, 2023
- Reason for recall
- Subpotency: one product for active ingredient assay and another one for preservative assay
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Sep 1, 2021
- Initial firm notification
- Telephone
- Center classification date
- Sep 20, 2021