Batch of Tofajak Tablets earlier classified as NSQ now flagged as Spurious

Written By :  Dr. Divya Colin
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-05-04 12:30 GMT   |   Update On 2025-05-04 12:30 GMT
Advertisement

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.

Advertisement

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.

'The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug.' the CDSCO stated in its revised alert.

The matter is now under active investigation. While the product is currently listed as “purportedly spurious,” the final classification will depend on the outcome of the ongoing inquiry.

Drug Alert for the Month of November–2024 (Revised)

List of Drugs, Medical Devices, Vaccines and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of November–2024 (Revised)

S.

No

Name of Drugs/medical device/cosmetics

Batch No.

Date of

Manufacture

Date of Expiry

Manufactured

by

Reason for failure

Drawn By

Firms’s reply

Remarks

40.

Tofacitinib Tablets IP 5 mg (TOFAJAK TABLETS)

4F30009

05/2024

04/2026

Under Investigation

Identification and Assay of Tofacitinib citrate calculated as Tofacitinib

Drugs Control Officer, Gurugram

The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug.

The product is purported to be spurious; however, the same is subject to outcome of investigation.

Also Read:Cipla gets CDSCO Panel nod to study Revefenacin Inhalation solution

To view the official notice, click the link below:

Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News