Bupivacaine spinal ampules recalled nationwide over lack of sterility assurance
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP ampules are being recalled for lack of assurance of sterility. The action covers 3,260,170 ampules.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a sterile injectable where sterility cannot be assured, a risk of harm with no injuries reported in the source.
Plain-English summary
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL, 7.5 mg/mL), supplied in 2 mL ampules, is being recalled. The NDC is 73293-0002-1 for the single ampule and 73293-0002-2 for the pack of 50 single-dose ampules. The product is manufactured in Korea. The action covers 3,260,170 ampules.
The stated reason is lack of assurance of sterility. Sterility is a defining requirement of an injectable product, and this formulation is used for spinal anesthesia. The FDA classified the action as Class II.
All lots within expiry are affected. Distribution was USA nationwide.
This is a prescription product supplied to healthcare facilities. Facilities should quarantine affected stock and follow the instructions issued by the manufacturer and distributors.
The recalled product
- Product
- BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
- Brand
- BUPIVACAINE HYDROCHLORIDE
- Manufacturer
- Huons Co., Ltd.
- Category
- Drug — Injectable anesthetic
- Affected units
- 3,260,170
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within expiry
UPCs (4)
- 0373293000218
- 0371351022509
- 0371351022028
- 0371351022103
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Huons Co., Ltd. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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