Ketorolac Tromethamine Injection recall: CGMP Deviations
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
Why was Ketorolac Tromethamine Injection recalled?
cGMP Deviations: deviations leading to potential cross-contamination.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot#: 023011 Exp 8/31/2022
- Product
- 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
- Recalling firm
- Nephron Sc Inc
- Quantity
- 5040 vials
- Distribution
- USA Nationwide
- Recall date
- August 24, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)