Hi-Tech Pharmacal Recalls Clobetasol Propionate Cream Due to Labeling Error
Hi-Tech Pharmacal is recalling Clobetasol Propionate Cream because some cartons contain tubes with gel labels. The actual product inside is the correct cream.
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 recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a labeling mix-up where the container label does not match the tube label, but the actual product inside is correct.
Plain-English summary
Hi-Tech Pharmacal Co., Inc. is recalling 58,812 tubes of Clobetasol Propionate Cream, USP, 0.05%, 15 grams. The recall is due to a labeling mix-up where some unit cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol Propionate Gel USP. The source text confirms that the actual product inside the tubes is Clobetasol Propionate Cream USP.
The affected product is identified by Batch/Lot 619442 with an expiration date of 01/2015. The product was distributed nationwide and in Puerto Rico. This is a prescription-only medication intended for dermatologic use.
Consumers should check their medication for the specific lot number and expiration date. If the product matches the description, they should stop using it and contact their healthcare provider or pharmacist for instructions on disposal or replacement.
The recalled product
- Product
- Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Pharmacal, Co., Inc., Amityville, NY 11701, NDC 50383-267-15 --- For dermatologic use only. Product is packaged into tubes and then placed into unit cartons.
- Manufacturer
- Hi-Tech Pharmacal Co., Inc.
- Category
- Drug — Topical Steroid
- Hazard
- Affected units
- 58,812
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)
- Batch/Lot 619442
- exp. 01/2015
Distribution
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