Class II · Moderate risk
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection
Lack of Assurance of Sterility
Marcaine (bupivacaine HCl) (Bupivacaine Hydrochloride)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.
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
Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.
Affected NDC
0409-1559-30
Compare with the code on your package — it is the most precise check available.
Drug: Bupivacaine
- Recalling firm
- Hospira Inc.
- NDC code
- 0409-1559-30
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1161-2014 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. 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 Hospira Inc.
All 2013 recalls
Class I · High risk
Infant 25% DEXTROSE Injection
Presence of Particulate Matter: human hair found within an internal sample syringe.
Class II · Moderate risk
Fentanyl Citrate Injection
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Class II · Moderate risk
DOBUTamine Injection
Discoloration: Firm received complaints of product discoloration and particulates.
Class III · Low risk
5% Lidocaine HCL and 7.5% Dextrose Injection
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.