Sprayology Recalls PMS Support Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling 647 bottles of PMS Support Homeopathic Oral Spray due to manufacturing 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 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: The recall is classified as FDA Class II and involves a theoretical risk of microbial contamination without reported illnesses, fitting the criteria for a voluntary precautionary recall or low-risk contamination.
Plain-English summary
Sprayology is voluntarily recalling 647 bottles of PMS Support, Homeopathic Oral Spray, 1.38 fl. oz (41ml). The product is identified by NDC 61096-0031-1 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, representing Current Good Manufacturing Practice (CGMP) deviations.
The affected product was distributed nationwide in the USA. No specific illnesses or injuries have been reported in the source text.
Consumers should stop using the product and contact Sprayology for further instructions or a refund.
The recalled product
- Product
- PMS Support, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0031-1
- Manufacturer
- Sprayology
- Category
- Drug — Homeopathic
- Hazard
- Affected units
- 647
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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