Generic Name: Sulpiride Hydrochloride Brand Name: Barnecil Tablets 100
- Recalling firm
- Name of Manufacturer and Distributor: Kyowa Pharmaceutical Industries, Ltd. Address of Manufacturer and Distributor: 3-2-4 Nakanoshima, Kita-ku, Osaka City, Osaka Prefecture Type of License: Class...
- Product
- Lot: ＜バラ1000錠＞ ロット 数量 出荷時期 2302 523 2023/05/10 ～ 2023/09/11 2312 80 2023/09/11 ～ 2023/10/02 2316 80 2023/10/02 ～ 2023/11/02 2317 81 2023/10/04 ～ 2023/11/07 2318 80 2023/11/02 ～ 2023/12/01 2319 80 2023/11/29 ～ 2023/12/13 2324 165 2023/12/01 ～ 2024/02/01 2325 889 2024/01/22 ～ 2024/09/11 2326 80 2024/09/11 ～ 2024/10/04 2327 80 2024/10/04 ～ 2024/10/21 2401 929 2024/10/21 ～ 2025/06/06 2403 915 2025/06/06 ～ 2026/01/27 ＜PTP100錠＞ ロット 数量 出荷時期 2302 3,447 2023/05/10 ～ 2023/07/04 2305 618 2023/07/03 ～ 2023/08/01 2306 603 2023/07/07 ～ 2023/08/01 2307 608 2023/08/01 ～ 2023/08/09 2308 779 2023/08/01 ～...
- Reason
- The results of the annual monitoring (at the 12-month mark) for this product (Lot 2402) indicated that the dissolution rate did not meet the approved specification (85% or more at 30 minutes). Since we cannot rule out the possibility that dissolution rates for other lots may also be out of specification, we have decided to voluntarily recall all lots currently on the market that are within their expiration dates.
- Classification
- Class II
- Category
- drug recall
- Country
- Japan
- Agency
- PMDA-DRUG
- Recall date
- 2026-02-03
- Status
- Ongoing
Official recall notice from PMDA-DRUG
Recall details on Nibble Recalls: https://trynibble.app/recalls/380e94a1-ecd6-490a-98a3-4a3d083c3173