Sprayology Recalls Acne Tonic Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling 919 bottles of Acne Tonic Homeopathic Oral Spray because manufacturing conditions could result in possible microbial contamination.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential contamination risks like microbial contamination, even without reported hospitalizations.
Plain-English summary
Sprayology is voluntarily recalling 919 bottles of Acne Tonic Homeopathic Oral Spray 1.38 fl. oz. (41 mL), NDC 61096-0027-1. The product was distributed nationwide in the USA. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically because the product was manufactured by a contract manufacturer under conditions that could result in possible microbial contamination.
The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The source text does not report any specific illnesses or injuries associated with this product.
Consumers who have purchased this product should stop using it and contact Sprayology for further instructions or a refund. The recall covers all lots within the expiry date.
The recalled product
- Product
- Acne Tonic Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0027-1
- Manufacturer
- Sprayology
- Category
- Drug — Homeopathic
- Hazard
- Affected units
- 919
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.
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