CLASS II Drug recall · Reported 20 May 2015 · FDA Enforcement Report
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit recalled
Mission Pharmacal is recalling Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit, distributed nationwide in the US. The recall was initiated on 30 Apr 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1064-2015
- FDA event ID
- 71072
- Recalling firm
- Mission Pharmacal, Boerne, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Apr 2015
- FDA classified
- 11 May 2015
- Reported
- 20 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
Timeline
| 30 Apr 2015 | Recall initiated by company | |
| 11 May 2015 | Classified by FDA | +11 days |
| 20 May 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Which lots are affected?
Lot #: 119814, Exp 05/31/2016
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 71072| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen recalled | Mission Pharmacal | Sterility | Nationwide |
More recalls from Mission Pharmacal
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen recalled | Mission Pharmacal | Sterility | Nationwide |
| Drug | CLASS III | Sodium Sulfacetamide 10% and Sulfur 5% Lotion recalled | Mission Pharmacal | Potency & Assay | Nationwide |