Bausch Health Recalls Subpotent Hydrocortisone Butyrate Cream
Bausch Health is recalling 35,424 tubes of Hydrocortisone butyrate Cream, 0.1%, because the product was found to be subpotent.
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 source text explicitly identifies the agency classification as Class II. According to the rubric, if the agency's own classification is FDA Class II, the score must be at least 4 (Severe).
Plain-English summary
Bausch Health Companies, Inc. is voluntarily recalling 35,424 units of Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes. The product is prescription-only and was manufactured for Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, by Ferndale Laboratories, Inc. The recall was initiated on July 13, 2020, and the product was distributed nationwide within the United States.
The reason for the recall is that the drug was found to be subpotent, meaning it did not contain the full amount of the active ingredient required by the label. The affected lots are 18125C (Exp. 09/2020), 19079B (Exp. 5/2021), 19142B (Exp. 09/2021), and 19167B (Exp. 10/2021). The FDA classified this recall as Class II, which indicates a situation that could cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for a replacement or refund. The recall status is currently terminated, having been closed on March 3, 2022.
The recalled product
- Product
- Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for Oceanside Pharmaceuticals a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, By: Ferndale Laboratories, Inc. Ferndale, MI 48220, NDC 68682-270-15
- Manufacturer
- Bausch Health Companies, Inc.
- Category
- Drug — Topical Steroid
- Hazard
- Affected units
- 35,424
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 (8)
- Lot #: 18125C
- Exp. Date 09/2020
- 19079B
- Exp. Date 5/2021
- 19142B
- Exp. Date 09/2021
- 19167B
- Exp. Date 10/2021
Distribution
Distributed nationwide across the United States.
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