Class II · Moderate risk
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection
Lack of Assurance of Sterility
BUPivacaine HCl 0.25% Preservative Free
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Particulate Matter: The bupivacaine HCl injection used to compound this lot of BUPivacaine HCl 0.25% Preservative Free 500 mL in On-Q C-bloc was recalled by the supplier due to a customer complaint of visible particles embedded in the glass vial.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-14 mL/hr) bag, Healix Infusion Therapy, Inc., 1075 West Park One Drive, Suite 200, Sugar Land, Texas 77478, NDC 75901-7210-53.
Affected NDC
75901-7210-53
Compare with the code on your package — it is the most precise check available.
Drug: Bupivacaine
- Recalling firm
- Healix Infusion Therapy, Inc.
- NDC code
- 75901-7210-53
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1422-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Bupivacaine recalls
See all
Class II · Moderate risk
BUPIVAcaine HCL Sterile injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
fentaNYL Citrate PF 200 mcg/100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL Citrate PF 200 mcg/100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 500 mcg/100 mL
Lack of Assurance of Sterility
Other recalls by Healix Infusion Therapy, Inc.
All 2014 recalls
Class II · Moderate risk
fentaNYL 5000 mcg/250 mL
Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.
Class II · Moderate risk
fentaNYL 2750 mcg/55 mL
Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.
Class II · Moderate risk
fentaNYL 200 mcg/100 mL
Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.
Class II · Moderate risk
fentaNYL 2500 mcg/250 mL
Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.
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