SOMERSET THERAPEUTICS LLC recalls Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Some…
- Recall date
- December 16, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0169-2025
- FDA classification
- Class III
- Brand / firm
- SOMERSET THERAPEUTICS LLC
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Failed Impurities/Degradation Specifications
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01
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