Drug recall
Acne Tonic Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC…
FDA recall event 81218 · Class II · Sprayology
Key facts
| Event ID | 81218 |
|---|---|
| Recall numbers | D-0105-2019, D-0106-2019, D-0107-2019, D-0108-2019, D-0109-2019, D-0110-2019, D-0111-2019, D-0112-2019, D-0113-2019, D-0114-2019, D-0115-2019, D-0116-2019 and 10 more |
| Recalling firm | Sprayology |
| Product type | Drugs |
| Products | Acne Tonic Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0027-1, AllergEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0003-1, Arnica Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0032-1, Body Balance, Homeopathic Oral Spray 1.38 fl. oz (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0039-1, Body Skin Tonic, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0017-1 and 17 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. |
| Initiation date | Oct 9, 2018 |
| Report date | Nov 7, 2018 |
| Termination date | Apr 18, 2019 |
| City | Gaithersburg |
| State | MD |
| Country | United States |
| FEI number | 3010630573 |
At a glance
- 10–99 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: