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Shilpa Medicare Limited: PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmeda

DrugsSource: FDA (drug) · Date: 2026-08-26

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Shilpa Medicare Limited
Product
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
Reason / hazard
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide in the USA.
Recall initiated
2026-07-29
Code info
Lot: P400172; Lot PA00050A, Exp 09/30/2027
Product quantity
18,434 10mL vials
Voluntary mandated
Voluntary: Firm initiated
City
Jadcherla, Mahabubnagar District
Country
India
Event id
99530
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