OFFICIAL-SOURCE RECALL · UNITED KINGDOM
Class 2 Medicines : Amarox Limited, Sertraline 100mg film-coated Recall: of more pronounced serotonergic
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
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Is your product affected?
- Brand
- See official notice
- Product
- Class 2 Medicines Recall: Amarox Limited, Sertraline 100mg film-coated tablets, EL(26)A/22
- Manufacturer
- See official notice
- GTIN
- 05060608561834
- Lot number
- batch-numbers, Batch, V2500425, stated, and, number, Number, V2500351
- Batch number
- numbers, Numbers, V2500425, stated, and, number, Number, V2500351
- Date code
- date can be found printed on th, Date, date can be
- Expiration date
- date can be found printed on th, Date, date can be
The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
of more pronounced serotonergic effects. The risk is however higher in patients with pre-existing cardiac conditions, those aged over 65 years, or those taking concomitant serotonergic or QT prolonging medication. Additionally, as some patients may require monitoring, including patients over 65 years old or under 18 years old, those with hepatic impairment and individuals who are known to be, or predicted to be a poor metaboliser for CYP2C19 substrates and therefore other clinicians and healthcare professionals may need to be involved. Healthcare professionals should be aware that only the batch stated in this notification is impacted. Advice for Healthcare Professionals to Provide to Patients: Some cartons of Sertraline 100 mg film-coated tablets, manufactured by Amarox Limited, may contain a blister strip(s) of Citalopram 40 mg tablets. All packs of Sertraline 100 mg film-coated tablets, Batch Number V2500425, are being recalled as a precautionary measure. If you have been prescribed Sertraline 100 mg film-coated tablets and have received impacted product (Batch Number V2500425), please check that the carton contains the correct medication. The batch number and expiry date can be
Hazard
of more pronounced serotonergic effects. The risk is however higher in patients with pre-existing cardiac conditions, those aged over 65 years, or those taking concomitant serotonergic or QT prolonging medication. Additionally, as some patients may require monitoring, including patients over 65 years old or under 18 years old, those with hepatic impairment and individuals who are known to be, or predicted to be a poor metaboliser for CYP2C19 substrates and therefore other clinicians and healthcare professionals may need to be involved. Healthcare professionals should be aware that only the batch stated in this notification is impacted. Advice for Healthcare Professionals to Provide to Patients: Some cartons of Sertraline 100 mg film-coated tablets, manufactured by Amarox Limited, may contain a blister strip(s) of Citalopram 40 mg tablets. All packs of Sertraline 100 mg film-coated tablets, Batch Number V2500425, are being recalled as a precautionary measure. If you have been prescribed Sertraline 100 mg film-coated tablets and have received impacted product (Batch Number V2500425), please check that the carton contains the correct medication. The batch number and expiry date can be
Official recall notice
Class 2 Medicines Recall: Amarox Limited, Sertraline 100mg film-coated tablets, EL(26)A/22
Agency: Medicines and Healthcare products Regulatory Agency
Official publication date: April 28, 2026
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