Recalls / Class III
Class IIID-0169-2025
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 name
- Atropine Sulfate
- Generic name
- Atropine Sulfate Monohydrate
- Active ingredient
- Atropine Sulfate
- Route
- Ophthalmic
- NDC
- 70069-716
- FDA application
- ANDA217791
- Affected lot / code info
- Lot #: A240211, Exp. Date April 2026
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- SOMERSET THERAPEUTICS LLC
- Manufacturer
- Somerset Therapeutics, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 300 Franklin Square Dr, Somerset, New Jersey 08873-4187
Distribution
- Quantity
- 5,870 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2024-12-16
- FDA classified
- 2024-12-31
- Posted by FDA
- 2025-01-08
- Terminated
- 2025-06-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0169-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.