The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1065-2015·Announced 2015-05-20

Mission Pharmacal Recalls Sodium Sulfacetamide and Sulfur Wash Kits

Mission Pharmacal is recalling 1,992 kits of Sodium Sulfacetamide 9% and Sulfur 4.5% Wash due to microbial contamination.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures.

Plain-English summary

Mission Pharmacal Co is recalling 1,992 kits of Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen. The product is prescription-only and includes a sunscreen with Broad Spectrum SPF 25. The specific lot number is 526014, with an expiration date of 05/31/2016.

The recall was initiated because the product failed the USP Microbial Limits Test, indicating microbial contamination of the non-sterile product. The affected units were distributed nationwide and in Puerto Rico.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for instructions on how to return the product or obtain a replacement.

The recalled product

Product
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen, Rx Only, Sunscreen Broad Spectrum SPF 25, Net Wt. 3 oz (85 g), Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Net Wt. 16 oz (454 g), Manufactured for: BioComp Pharma Inc., San Antonio TX, 78230, NDC 44523-616-23
Manufacturer
Mission Pharmacal Co
Category
Drug — Topical Prescription
Hazard
Affected units
1,992

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 526014
  • Exp. 05/31/2016

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Mission Pharmacal Co under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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