United StatesPEMRYDI RTU (pemetrexed injection) single‑dose vials 100 mg/10 mL (NDC 70121‑2453‑1) and 500 mg/50 mL (NDC 70121‑2461‑1), manufactured by Zydus Lifesciences and distributed by Amneal Pharmaceuticals, in lots P400172, P400157, PA00050A, and PA00047A are being recalled by Shilpa Medicare Limited. The recall was initiated after market complaints of green to dark green discoloration in certain vials; these products were distributed nationwide in the USA.
What's being recalled
PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2453-1
PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2461-1
Recalling firm: Shilpa Medicare Limited, Jadcherla, Mahabubnagar District, India.
How to identify it
Lot: P400172; Lot PA00050A, Exp 09/30/2027 Lot: P400157, Exp 08/31/2026; Lot PA00047A, Exp 09/30/2027
The hazard
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
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
Nationwide in the USA.
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)