December 2024 FDA Recall Atropine Sulfate by Somerset Therapeutics Llc
D-0169-2025 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Somerset Therapeutics Llc on December 16, 2024 for the product Atropine Sulfate. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0169-2025
Failed Impurities/Degradation Specifications
12-16-2024
01-08-2025
5,870 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
SOMERSET THERAPEUTICS LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
06-10-2025
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01
Batch or Lot Expiration Information
Lot# : A240211, Exp. Date April 2026
