Batch of Tofajak Tablets earlier classified as NSQ now flagged as Spurious
New Delhi: Through a recent revised drug alert, the Central Drugs Standard Control Organization (CDSCO) has classified a batch of Tofacitinib Tablets IP 5 mg (TOFAJAK TABLETS) as spurious. The batch was earlier classified as Not of Standard Quality (NSQ).
The Medical Dialogues team had reported that 41 drug formulations were declared as Not of Standard Quality (NSQ) in November 2024, based on testing conducted by various CDSCO laboratories. Among these was a batch of Tofacitinib Tablets IP 5 mg (TOFAJAK TABLETS) (Batch No. 4F30009), listed under Cipla LTD , which was flagged by the Regional Drugs Testing Laboratory (RDTL) Chandigarh for failing identification and assay of Tofacitinib citrate calculated as Tofacitinib.
However, the same batch has now also been classified as “purportedly spurious” in CDSCO’s revised alert, with Cipla informing that it did not manufacture this batch.
The batch in question — Batch No. 4F30009, with a manufacturing date of May 2024 and expiry of April 2026 — carries Cipla’s name on the label. However, the company has officially clarified that it did not manufacture this particular batch.
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