Drug recall
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics…
FDA recall event 95997 · Class III · SOMERSET THERAPEUTICS LLC
Key facts
| Event ID | 95997 |
|---|---|
| Recall numbers | D-0169-2025 |
| Recalling firm | SOMERSET THERAPEUTICS LLC |
| Product type | Drugs |
| Products | Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications |
| Initiation date | Dec 16, 2024 |
| Report date | Jan 8, 2025 |
| Termination date | Jun 10, 2025 |
| City | Somerset |
| State | NJ |
| Country | United States |
| FEI number | 3013895162 |
At a glance
- 1–9 Products in this recall
- 1–9 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: