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.
What this means for you
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
- manufacturing-defect
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.
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