D-0124-2017 Class II Terminated
FDA drug recall D-0124-2017 was initiated by Akorn Inc on Oct 21, 2016 and is designated Class II. Reason for recall: Subpotent Drug: concentration of product is less than labeled amount. The recall status is terminated (terminated May 10, 2019). Affected quantity: 29,972 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 9, 2016
- Initiation Date
- Oct 21, 2016
- Termination Date
- May 10, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29,972 bottles
Product Description
Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.
Reason for Recall
Subpotent Drug: concentration of product is less than labeled amount.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot: 041306A, Exp 04/19
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0124-2017
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026