D-1354-2022 Class II Terminated
FDA drug recall D-1354-2022 was initiated by Nephron Sc Inc on Aug 10, 2022 and is designated Class II. Reason for recall: cGMP Deviations: deviations leading to potential cross-contamination. The recall status is terminated (terminated Sep 24, 2024). Affected quantity: 5040 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 24, 2022
- Initiation Date
- Aug 10, 2022
- Termination Date
- Sep 24, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5040 vials
Product Description
Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01
Reason for Recall
cGMP Deviations: deviations leading to potential cross-contamination.
Distribution Pattern
USA Nationwide
Code Information
Lot#: 023011 Exp 8/31/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1354-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026