United StatesHADLIMA (adalimumab‑bwwd) injection 40 mg/0.8 mL, sold as cartons containing 2 single‑dose prefilled syringes (NDC 78206‑183‑01), Lot F2505017, Expiry 24‑Jan‑2027, is affected. Samsung Bioepis recalled these units due to a lack of assurance of sterility; the recalled product was distributed only to one warehouse in New Jersey with no further distribution.
What's being recalled
HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured by: SAMSUN BIOEPIS Co., Ltd, Incheon, Republic of Korea, NDC 78206-183-01.
Recalling firm: Samsung Bioepis Co., Ltd., Yeonsu, N/A, Korea (the Republic of).
How to identify it
Lot: F2505017, Expiry: 24-Jan-2027
The hazard
Lack of Assurance of Sterility.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Distributed only to one warehouse in NJ. with no further distribution
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)