D-0671-2026 Class II Ongoing

Recalled by Reliance Life Sciences Private Limited — Navi Mumbai, N/A

FDA drug recall D-0671-2026 was initiated by Reliance Life Sciences Private Limited on June 24, 2026 and is designated Class II. Reason for recall: Lack of Sterility Assurance The recall status is ongoing. Affected quantity: 12,000 vials.

Recall Details

Product Type
Drugs
Report Date
July 15, 2026
Initiation Date
June 24, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12,000 vials

Product Description

Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0834-01

Reason for Recall

Lack of Sterility Assurance

Distribution Pattern

Nationwide in the USA

Code Information

Lot, expiry: RPTL0325A Dec 31, 2027; RPTL0425A Dec 31, 2027; RPTL0624B Nov 30,2027; RPTL0625A Mar 31, 2028