FDAHealthDecember 16, 2024
SOMERSET THERAPEUTICS LLC — Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01
⚠️ Failed Impurities/Degradation Specifications
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 16, 2024
Nationwide within the United States
What's affected?
- Product
- Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01
- Brand
- ATROPINE SULFATE
- UPC
- 0370069716014
- Lot code
- A240211
Additional details
Lot #: A240211, Exp. Date April 2026
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 5,870 bottles.
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