Drug Recall: SnoreStop Naso Spray Bulk for cGMP Manufacturing Deviations
Homeocare Laboratories is recalling SnoreStop Naso Spray Bulk due to current Good Manufacturing Practice (cGMP) deviations. This voluntary recall affects product distributed nationwide in 55-gallon drums.
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: This is an FDA Class II recall involving manufacturing practice deviations with no reported illnesses, injuries, or deaths. Per the rubric, voluntary precautionary recalls without reported harm warrant a Moderate severity score.
Plain-English summary
Homeocare Laboratories, Inc. is recalling SnoreStop Naso Spray Bulk (NDC 61152-199-99) distributed by Green Pharma. The affected product is a liquid nasal spray supplied in 200-liter/55-gallon drums with Lot # 2436. The product was distributed nationwide throughout the United States.
The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations in the manufacturing process. This is a voluntary recall initiated by the firm, reported to the FDA on July 5, 2023, with the recall process beginning on June 5, 2023.
Consumers or healthcare facilities that have received this product should discontinue use and contact Homeocare Laboratories, Inc. for instructions on return or disposal. The recall was terminated on September 16, 2024.
The recalled product
- Product
- SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99
- Manufacturer
- Homeocare Laboratories, Inc.
- Category
- Drug — Nasal Spray
- Hazard
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 # 2436
- exp. date: unknown
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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