Sprayology Recalls DigestivEase Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling 1,465 bottles of DigestivEase Homeopathic Oral Spray due to manufacturing conditions that could result in microbial contamination.
What this means for you
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 (microbial contamination) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Sprayology is recalling 1,465 bottles of DigestivEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml). The product is identified by NDC 61096-0005-1 and includes all lots within expiry. The recall was initiated because the product was manufactured by a contract manufacturer under conditions that could result in possible microbial contamination.
The affected product was distributed nationwide in the USA. This recall addresses Current Good Manufacturing Practice (CGMP) deviations that pose a risk of microbial contamination.
Consumers who have this product should stop using it and contact Sprayology for further instructions or a refund.
The recalled product
- Product
- DigestivEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0005-1
- Manufacturer
- Sprayology
- Category
- Drug — Homeopathic
- Hazard
- Affected units
- 1,465
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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