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
Reported: August 24, 2022 Initiated: August 10, 2022 #D-1354-2022
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.
Details
- Recalling Firm
- Nephron Sc Inc
- Units Affected
- 5040 vials
- Distribution
- USA Nationwide
- Location
- West Columbia, SC
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Nephron Sc Inc. Units affected: 5040 vials.
Why was this product recalled? ▼
cGMP Deviations: deviations leading to potential cross-contamination.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 24, 2022. Severity: Moderate. Recall number: D-1354-2022.
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