GSK Pakistan voluntarily recalls 36 batches of Motival tablets due to Nitrosamine impurity

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Voluntary recall initiated due to potential carcinogenic impurity; healthcare professionals and consumers advised to take immediate action.

2025-02-20T15:51:00+05:00 Press Release

ISLAMABAD: GlaxoSmithKline (GSK) Pakistan Limited has announced a voluntary recall of 36 batches of Motival Tablets after detecting a nitrosamine impurity, N-nitroso nortriptyline, raising health concerns over its potential carcinogenic effects.

The company officially informed the Drug Regulatory Authority of Pakistan (DRAP) of the recall and confirmed that they have ceased the manufacturing and release of Motival Tablets with immediate effect. The DRAP Recall Alert has been issued on February 18, 2025 via DRAP Alert No. No I/S/02-25-18.

Recalled Product Details:

  • Product Name: Motival Tablets 5x20’s (Reg # 004539)
  • Composition: Nortriptyline HCl 10mg + Fluphenazine HCl 0.5mg
  • Batch Numbers: 9P8L, A95S, A95Y, AN5N, AN5P, AN5R, AN5T, CK7G, CK7H, DT7B, DT7D, DL8J, DT7C, H58X, H58Y, H59A, J77W, J77V, K36F, K36E, KD6N, KD6P, M32F, ME8N, ME8R, R47H, R47K, R47L, SA7F, SA7G, SA6V, WM8R, WM8T, WM8U, YB7A, YB7B.
  • Manufactured by: GSK Pakistan Limited, Plot #5, Sector 21, Korangi Industrial Area, Karachi.

Health Risk Statement:

The risk of nitrosamine impurity in nortriptyline, like other pharmaceutical products, is a broader concern that became more prominent after several incidents. These impurities are believed to have carcinogenic potential in certain situations.

Actions Initiated:

  • The regulatory field force of DRAP and Provincial Drug Control departments have been instructed to conduct market surveillance to detect and remove recalled batches.
  • Pharmacists and chemists are advised to immediately check their stock, stop supplying the mentioned product, quarantine remaining stock, and return it to the supplier.
  • Healthcare professionals are urged to increase vigilance within supply chains and report any adverse reactions or quality problems to the National Pharmacovigilance Centre (NPC), DRAP.

Advice for Consumers:

  • Consumers are advised to stop using Motival Tablets bearing the affected batch numbers.
  • They should contact their physician or healthcare provider if they experience any problems linked to the use of this medication and report incidents to DRAP through the National Pharmacovigilance Centre.

For adverse event reporting, visit the official DRAP reporting link: DRAP Reporting Portal

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