CLASS II Drug recall · Reported 24 Aug 2022 · FDA Enforcement Report
Ketorolac Tromethamine Injection, USP 60 mg/ (30 mg/mL) recalled
Nephron Sc is recalling Ketorolac Tromethamine Injection, USP 60 mg/ (30 mg/mL), distributed nationwide in the US. The recall was initiated on 10 Aug 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1354-2022
- FDA event ID
- 90703
- Recalling firm
- Nephron Sc, West Columbia, SC
- Manufacturer
- Nephron Pharmaceuticals Corporation
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Aug 2022
- FDA classified
- 17 Aug 2022
- Reported
- 24 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 10 Aug 2022 | Recall initiated by company | |
| 17 Aug 2022 | Classified by FDA | +7 days |
| 24 Aug 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations: deviations leading to potential cross-contamination.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Is Ketorolac Tromethamine Injection, USP 60 mg/ (30 mg/mL) recalled?
Yes. Nephron Sc recalled Ketorolac Tromethamine Injection, USP 60 mg/ (30 mg/mL) on 10 Aug 2022. The recall is Class II and its status is Terminated. Recall number D-1354-2022.
Why was it recalled?
cGMP Deviations: deviations leading to potential cross-contamination.
Which lots are affected?
Lot#: 023011 Exp 8/31/2022
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Ketorolac Tromethamine recalls
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ketorolac Tromethamine Injection, USP, 60 mg recalled by Aspiro PharmaKetorolac Tromethamine | Aspiro Pharma | Particulate Matter | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine | Apotex | Sterility | Nationwide |
| Drug | CLASS I | Ketorolac Tromethamine Injection, USP, 30 mg per mL recalledKetorolac Tromethamine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Injection, USP, 60 mg per (30 mg per mL) recalledKetorolac Tromethamine | Fresenius Kabi USA | Particulate Matter | Nationwide |