Sprayology Recalls Snore Soother Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling Snore Soother Homeopathic Oral Spray because it was manufactured under conditions that could result in possible microbial contamination.
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 recall is classified as FDA Class II and involves a risk of microbial contamination, which meets the rubric criteria for a Severe rating.
Plain-English summary
Sprayology is recalling 1,055 bottles of Snore Soother, Homeopathic Oral Spray, 1.38 fl. oz (41ml). The product is identified by NDC 61096-0024-1 and includes all lots within expiry. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations.
The product was manufactured by a contract manufacturer under conditions that could result in possible microbial contamination. The recall is classified as FDA Class II.
The product was distributed nationwide in the USA. Consumers should stop using the product and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Snore Soother, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0024-1
- Manufacturer
- Sprayology
- Category
- Drug — Homeopathic
- Hazard
- Affected units
- 1,055
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)
- All lots within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Sprayology 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.
See all 22 products in this recall →Related recalls
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