Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7...
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
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 Products
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)
Additional Source Details
| Field | Value |
|---|---|
| City | Jecheon |
| State | N/A |
| Openfda › Upc › 1 | 0373293000218 |
| Openfda › Upc › 2 | 0371351022509 |
| Openfda › Upc › 3 | 0371351022028 |
| Openfda › Upc › 4 | 0371351022103 |
| Openfda › Unii | 7TQO7W3VT8 |
| Openfda › Route | SUBARACHNOID |
| Openfda › Rxcui | 1724784 |
| Openfda › Spl id › 1 | 2e641a0d-4d42-e7cd-e063-6394a90a47d4 |
| Openfda › Spl id › 2 | 484033d6-ca7d-f0fd-e063-6294a90a7890 |
| Openfda › Brand name | BUPIVACAINE HYDROCHLORIDE |
| Openfda › Spl set id › 1 | 2dc693df-3218-4a90-b3f7-21e80966a851 |
| Openfda › Spl set id › 2 | e8b32972-6984-4f1c-e053-2995a90a3277 |
| Openfda › Package ndc › 1 | 73293-0002-1 |
| Openfda › Package ndc › 2 | 73293-0002-2 |
| Openfda › Package ndc › 3 | 71351-022-02 |
| Openfda › Package ndc › 4 | 71351-022-50 |
| Openfda › Package ndc › 5 | 71351-022-10 |
| Openfda › Product ndc › 1 | 73293-0002 |
| Openfda › Product ndc › 2 | 71351-022 |
| Openfda › Generic name | BUPIVACAINE HYDROCHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | BUPIVACAINE HYDROCHLORIDE |
| Openfda › Manufacturer name › 1 | Huons Co., Ltd. |
| Openfda › Manufacturer name › 2 | Brookfield Pharmaceuticals, LLC. |
| Openfda › Application number | ANDA212822 |
| Openfda › Is original packager | true |
| Event id | 98724 |
| Address 1 | 100 Bio-Valley-Ro |
| Address 2 | N/A |
| Code info | All lots within expiry |
| Postal code | N/A |
| Report date | 20260422 |
| Product type | Drugs |
| Product quantity | 3,260,170 ampules |
| Reason for recall | Lack of Assurance of Sterility |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260402 |
| Initial firm notification | N/A |
| Center classification date | 20260515 |
Overview
- Recalling FirmHuons Co., Ltd.
- StatusOngoing
- Risk LevelClass II
- DistributionUSA Nationwide.