The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1064-2015·Announced 2015-05-20

Mission Pharmacal Recalls Sodium Sulfacetamide and Sulfur Wash Kits

Mission Pharmacal is recalling 2,412 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant hazards like microbial contamination in pharmaceutical products.

Plain-English summary

Mission Pharmacal Co is recalling 2,412 kits of Sodium Sulfacetamide 9% and Sulfur 4.5% Wash, manufactured for BioComp Pharma Inc. The affected product is a prescription-only wash kit containing a 16 oz (454 g) wash and a 16 fl. oz. (473 mL) daily moisturizing wash.

The recall was initiated because the product failed the USP Microbial Limits Test, indicating microbial contamination. The specific lot number is 119814, with an expiration date of 05/31/2016. The product was distributed nationwide and in Puerto Rico.

Consumers should stop using the product and return it to the pharmacy or point of purchase for a refund or replacement. This recall is classified as FDA Class II, meaning there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
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
Manufacturer
Mission Pharmacal Co
Category
Drug — Topical Prescription
Hazard
Affected units
2,412

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 #: 119814
  • 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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