Generic Names: (1) Oxygen (2) Liquid Oxygen — Trade Names: (1) Japanese Pharmacopoeia Oxygen — (2) Liquid Oxygen
- Recalling firm
- Name of Manufacturer and Distributor: Taiyo Nissin Co., Ltd. — Address of Manufacturer and Distributor: 1-3-26 Koyama, Shinagawa-ku, Tokyo — Type of License: Type II Pharmaceutical Manufacturing...
- Product
- Lot: （１）日本薬局方酸素 出荷期間及び該当する容器の記号番号 出荷期間：2025年9月24日〜2025年10月15日 1BIS-30238 1BIS-7188 1BIS-7190 1BIS-7196 1BIS-91631 1H-36746 1H-38755 1H-49719 1H-69511 1H-69515 1H-90050 1H-93396 1H-98270 1J-33583 1MK-29622 1PEI-0497 1PEI-18822 1PEI-26717 1PEI-26720 1PEI-30348 1PEI-30349 1PEI-30351 1PEI-4429 1PEI-4434 1PEI-49400 1PEI-49409 1PEI-49412 1PEI-49414 1PEI-53630 1PEI-58144 1PEI-58892 1PEI-69606 1PEI-77167 1PEI-77168 1PEI-77170 1PEI-77266 1PEI-78484 1PEI-87155 1PEI-87156 1PEI-87195 1PEI-89748 1PEI-89751 1PEI-89758 1PEI-89974 1PEI-95148 1X-1633 1X-98498 2-6463 2BIS-31719 2H-03239 2H-35164 2H-49257...
- Reason
- We have discovered that, in the production of certain batches of Japanese Pharmacopoeia-grade oxygen and liquid oxygen (filled into portable cryogenic gas cylinders) that we manufacture and sell, a pharmaceutical raw material (liquid oxygen) that did not comply with our manufacturing specifications was inadvertently used. As a result, we are recalling the products described above.
- Classification
- Class III
- Category
- drug recall
- Country
- Japan
- Agency
- PMDA-DRUG
- Status
- Ongoing
Official recall notice from PMDA-DRUG
Recall details on Nibble Recalls: https://trynibble.app/recalls/bddca59b-999e-42d9-b104-86df16cefe34