Mission Pharmacal Recalls Sodium Sulfacetamide and Sulfur Lotion Due to Incorrect Formulation
Mission Pharmacal Co is recalling 8,437 bottles of Sodium Sulfacetamide 10% and Sulfur 5% Lotion because the active ingredients were formulated too high.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Mission Pharmacal Co is voluntarily recalling 8,437 bottles of Sodium Sulfacetamide 10% and Sulfur 5% Lotion (NDC 42792-102-01), 25 g. The product was manufactured for Austin Pharmaceuticals, LLC, Wilmington, DE.
The recall was initiated because the drug product's active ingredients were formulated incorrectly, resulting in concentrations that were too high relative to the label strength. This is classified as a Class III recall by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The affected lots are Lot# E112 (Exp 05/14) and Lot# J062 (Exp 09/14). The product was distributed nationwide. Consumers should stop using the product and contact their pharmacist or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE
- Manufacturer
- Mission Pharmacal Co
- Category
- Drug — Topical Dermatological
- Hazard
- Affected units
- 8,437
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 (3)
- Lot# E112
- Exp 05/14 Lot# J062
- Exp 09/14
Distribution
Distributed nationwide across the United States.
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