H & H Remedies Recalls Vapor Ointment Due to Manufacturing Deviations
H & H Remedies, LLC is voluntarily recalling 252 jars of Vapor Ointment due to Current Good Manufacturing Practice (CGMP) deviations.
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: The recall is classified as FDA Class II and is voluntary, with no reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
H & H Remedies, LLC is voluntarily recalling 252 jars of Vapor Ointment. The product is packaged in 1/8 oz, 2 oz, 4 oz, and 8 oz jars and was distributed nationwide in the United States. The recall covers lot numbers H20-01V through H20-10V.
The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations. The company notified the public via a press release. The recall was initiated on October 21, 2020, and the FDA classified it as Class II.
Consumers who have the affected product should stop using it and contact the manufacturer for instructions on how to return or dispose of the product.
The recalled product
- Product
- Vapor Ointment packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; and d) 8 oz jars. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663
- Manufacturer
- H & H Remedies, LLC
- Category
- Drug — Topical Ointment
- Hazard
- Affected units
- 252
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 (1)
- Lot #: H20-01V thru H20-10V
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by H & H Remedies, LLC 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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