CLASS II Drug recall · Reported 27 Jul 2022 · FDA Enforcement Report
Bupivacaine HCl 150 mg (3.0 mg/mL) recalled
Nephron Sterile Compounding Center is recalling Bupivacaine HCl 150 mg (3.0 mg/mL), Ketorolac Tromethamine 60 mg (1.2 mg/mL), Ketamine, distributed nationwide in the US. The recall was initiated on 30 Jun 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-1249-2022
- FDA event ID
- 90512
- Recalling firm
- Nephron Sterile Compounding Center, West Columbia, SC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jun 2022
- FDA classified
- 18 Jul 2022
- Reported
- 27 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 30 Jun 2022 | Recall initiated by company | |
| 18 Jul 2022 | Classified by FDA | +18 days |
| 27 Jul 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Bupivacaine HCl 150 mg (3.0 mg/mL), Ketorolac Tromethamine 60 mg (1.2 mg/mL), Ketamine HCl 60 mg (1.2 mg/mL) Injection, 50 mL syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-514-50
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lots: BP2001A, Exp. 7/6/2022; BP2002A, Exp. 7/27/2022; BP2007A, Exp. 7/3/2022
Where was it sold?
Nationwide in the USA
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
36 other products · FDA event 90512This product is part of a recall event; the main page for the event is Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) syringe recalled.
More recalls from Nephron Sterile Compounding Center
All 73| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sodium Chloride Injection 9%, USP, Single-Dose IV recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCl Injection, USP, 0.8 mg recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCl Injection, USP, 0.4 mg recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
Other Bupivacaine recalls
All 54| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection recalledBupivacaine Hydrochloride | Huons | Sterility | Nationwide |
| Drug | CLASS II | BUPIVAcaine HCL Sterile injection recalled by Tailstorm Health | Tailstorm Health | Sterility | Nationwide |
| Drug | CLASS II | Sensorcaine (Bupivacaine HCl and Epinephrine Injection recalledSensorcaine | Fresenius Kabi USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection recalledSensorcaine | Fresenius Kabi USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Sensorcaine (Bupivacaine HCl and Epinephrine Injection recalledSensorcaine | Fresenius Kabi USA | Potency & Assay | Nationwide |