Class II · Moderate risk
BUPIVAcaine HCL Sterile injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea, NDC 73293-0002-1 (2 mL ampule), NDC 73293-0002-2 (50 x 2 Single-dose ampules); Distributed: Brookfield Pharmaceuticals, LLC, Brookfield, WI 53005, Made in S. Korea, NDC 71351-022-02 (ampule), NDC 71351-022-10 (10 count ampules), NDC 71351-022-50 (50 count ampules)
Affected NDCs
71351-0022-02
71351-0022-10
71351-0022-50
73293-0002-01
73293-0002-02
Compare with the code on your package — it is the most precise check available.
Drug: Bupivacaine
Product details
From the FDA NDC directory, for the product codes this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Bupivacaine Hydrochloride NDC 71351-0022 |
7.5 mg/mL | Injection Subarachnoid |
Brookfield Pharmaceuticals, LLC. | Rx |
| Bupivacaine Hydrochloride NDC 73293-0002 |
7.5 mg/mL | Injection Subarachnoid |
Huons Co., Ltd. | Rx |
- Recalling firm
- Huons Co., Ltd.
- NDC code
- 73293-0002-1
- Origin
- N/A, Korea (the Republic of)
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0530-2026 · 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.
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