Psoriasin Daytime Relief Cream Recalled for Subpotent Coal Tar Content
Alva-Amco Pharmacal Companies is recalling Psoriasin Daytime Relief Cream because it failed to maintain its label claim of coal tar throughout its expiry period.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classification is FDA Class III, which by definition is unlikely to cause adverse health consequences, aligning with the Low severity rubric for minor or theoretical risks.
Plain-English summary
Alva-Amco Pharmacal Companies, Inc. is recalling Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal (Coal Tar 1.25%). The product is packaged in 57 g plastic tubes and is distributed by Alva-Amco Pharmacal Cos., Inc. in Niles, IL.
The recall was initiated because the product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period. This is classified as a subpotent drug issue.
The affected product was distributed nationwide in the USA and in several international locations, including Italy, Sweden, Germany, New Zealand, Netherlands, Australia, Moldova, United Kingdom, Mexico, Brazil, Chile, Greece, Spain, Norway, Belgium, and Bulgaria. Consumers should check their lot numbers and expiration dates against the recall list and stop using the product if it matches the recalled lots.
The recalled product
- Product
- Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), packagedin 57 g plastic tubes, Distributed by: ALVA-AMCO Pharmacal Cos., Inc., Niles, IL 60714, USA. NDC 52389-745-56, UPC 0 72959 01045 4.
- Manufacturer
- Alva-Amco Pharmacal Companies., Inc.
- Category
- Drug — Topical Dermatology
- Hazard
- Affected units
- 206,513
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 (20)
- Lot #: 61031
- 61041
- 61051
- Exp. 4/30/2018
- 61601
- 61651
- 61751
- Exp. 6/30/2018
- 61941
- Exp. 7/31/2018
- 62321
- Exp. 8/31/2018
- 62561
- 62721
- Exp. 9/30/2018
- 62871
- Exp. 10/31/2018
- 63331
- Exp. 11/30/2018
- 72011
Distribution
Distributed nationwide across the United States.
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