Class II · Moderate risk Ongoing
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection
Reason Lack of Assurance of Sterility
0.4 mcg/mL Sufentanil Citrate and 0.0625% Bupivacaine HCl
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
What was recalled
0.4 mcg/mL Sufentanil Citrate and 0.0625% Bupivacaine HCl (Preservative Free), 150 mL in 150 mL Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-713-95
- Recalling firm
- Pharmedium Services, LLC
- NDC code
- 61553-713-95
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1369-2016
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Bupivacaine recalls
See all
Class II · Moderate risk Ongoing
BUPIVAcaine HCL Sterile injection
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk Ongoing
fentaNYL Citrate PF 200 mcg/100 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
fentaNYL Citrate PF 200 mcg/100 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL 500 mcg/100 mL
Reason Lack of Assurance of Sterility
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