Atropine Sulfate Solution/ Drops
FDA Recall NDC 70069-716
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Atropine Sulfate (NDC 70069-716). A significant event, classified as Class III, was initiated on Dec 16, 2024 by Somerset Therapeutics, Llc. The reported reason for this action was: "Failed Impurities/Degradation Specifications"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
December 2024 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications
Dec 16, 2024
Jan 08, 2025
5,870 bottles
Recall Profile & Regulatory Data
Event ID
95997
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
SOMERSET THERAPEUTICS LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Jun 10, 2025
Product Description
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
Affected Packages Involved in this Recall
70069-716-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
