Why it was recalled
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Product description
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit, Rx Only, Sodium Sulfacetamide 9% and Sulfur 4.5% Wash, Net Wt. 16 oz (454 g), Daily Moisturizing Wash, 16 fl. oz. (473 mL), Manufactured for: BioComp Pharma Inc., San Antonio, TX 78230, NDC 44523-0609-23
Lot numbers, UPCs & expiration codes
Lot #: 119814, Exp 05/31/2016
Where it was sold
Nationwide and Puerto Rico
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-1064-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 30, 2015
- FDA report date
- May 20, 2015
- Quantity
- 2,412 Kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mission Pharmacal Co
Original FDA data
Every field from FDA enforcement report D-1064-2015, exactly as published.
Show all FDA fields
- City
- Boerne
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 71072
- Address
- 38505 IH-10 West
- Code information
- Lot #: 119814, Exp 05/31/2016
- Postal code
- 78006
- Report date
- May 20, 2015
- Product type
- Drugs
- Recall number
- D-1064-2015
- Classification
- Class II
- Recalling firm
- Mission Pharmacal Co
- Product quantity
- 2,412 Kits
- Termination date
- Jan 26, 2017
- Reason for recall
- Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit, Rx Only, Sodium Sulfacetamide 9% and Sulfur 4.5% Wash, Net Wt. 16 oz (454 g), Daily Moisturizing Wash, 16 fl. oz. (473 mL), Manufactured for: BioComp Pharma Inc., San Antonio, TX 78230, NDC 44523-0609-23
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Apr 30, 2015
- Initial firm notification
- Letter
- Center classification date
- May 11, 2015