Sprayology Recalls Brain Power Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling Brain Power 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (possible microbial contamination) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Sprayology is recalling 2,054 bottles of Brain Power Homeopathic Oral Spray, 1.38 fl. oz (41ml), NDC 61096-0033-1. The product was distributed nationwide in the USA. All lots within expiry are affected.
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.
Consumers with this product should stop using it and contact Sprayology for further instructions.
The recalled product
- Product
- Brain Power,Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0033-1
- Manufacturer
- Sprayology
- Category
- Drug — Homeopathic
- Hazard
- Affected units
- 2,054
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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