PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmeda…
Shilpa Medicare Limited · Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
- Status
- Ongoing
- City
- Jadcherla, Mahabubnagar District
- Country
- India
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 99530
- Recalling firm
- Shilpa Medicare Limited
- Address 1
- Plot No. S20 to S26, Pharmaceutical Formulations SEZ
- Address 2
- TSIIC Green Industrial Park, Polepally (Village)
- Postal code
- N/A
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA.
- Recall number
- D-0764-2026
- Product quantity
- 18,434 10mL vials
- Reason for recall
- Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
- Recall initiation date
- 20260729
- Center classification date
- 20260814
- Report date
- 20260826
- Code info
- Lot: P400172; Lot PA00050A, Exp 09/30/2027
- Product description
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
- Harmonized identifiers (openFDA)
- Application number
- NDA215179
- Brand name
- PEMRYDI RTU
- Generic name
- PEMETREXED DISODIUM
- Manufacturer name
- Amneal Pharmaceuticals LLC
- Product NDC
- 70121-2453, 70121-2461, 70121-2462
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- PEMETREXED DISODIUM HEMIPENTAHYDRATE
- RxCUI
- 2637958, 2637964, 2637966, 2637967, 2637968, 2637969
- SPL ID
- b6a00be1-95d1-4b91-93bf-4430a57eeff6
- SPL set ID
- 0f006b06-ab85-423d-ba0c-dfc3fc25844e
- Package NDC
- 70121-2453-1, 70121-2461-1, 70121-2462-1
- Is original packager
- true
- Upc
- 0370121246213, 0370121246114, 0370121245315
- UNII
- F4GSH45R4C