Drug: Arnica 7 Cream Recalled for Manufacturing Standards Deviations
Homeocare Laboratories is recalling Arnica 7 Cream due to manufacturing standards deviations. The recall affects 2,376 bottles with lot number 2446.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA classified this as Class II. The recall is voluntary and based on manufacturing standards deviations rather than a confirmed contamination or identified injury hazard.
Plain-English summary
Homeocare Laboratories, Inc. is recalling Arnica 7 Cream (2 oz / 56.7g bottles) manufactured for Brazmedics, LLC due to deviations from current Good Manufacturing Practice (cGMP) standards. The product was distributed nationwide in the United States.
Affected lot: Lot # 2446, with expiration date March 2024. The recall covers 2,376 bottles. This is a voluntary recall initiated by the manufacturer on June 5, 2023.
Consumers who have this product should discontinue use. For instructions on return or disposal, consumers should contact Homeocare Laboratories.
The recalled product
- Product
- Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New York, NY 10021 UPC 8 60208 00181 6
- Manufacturer
- Homeocare Laboratories, Inc.
- Category
- Drug — Topical Cream
- Hazard
- Affected units
- 2,376
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 # 2446
- exp. Mar-24
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Homeocare Laboratories, Inc. 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.
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