Last alerts from category: Pharmaceuticals

Pharmaram Ltd has informed us that a specific batch of Clexane 4,000IU (40mg)/0.4ml syringes has an error on the labelling affixed to the plastic blister packaging encasing the syringe. The label incorrectly states “Clexane 6,000IU (60mg)/0.6ml Syringes”, when it should have stated “Clexane 4,000IU (40mg)/0.4ml Syringes”. The outer carton states the correct strength; the batch number and expiry dates are also correct and match the details on the labelling.

Pharmaceuticals
United Kingdom
04-08-2020
Pharmaceuticals
United Kingdom
04-08-2020

Crescent Pharma Ltd has informed us that the Patient Information Leaflet (PIL) within the packs for the above batches is missing important safety relevant text changes. The changes to the PIL include the addition of the following information:

  • Warnings and precautions Psychiatric disorders: Some women using hormonal contraceptives including SyreniRing have reported depression or depressed mood.
  • Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.

It is important that any patients are provided with information on warnings and precautions whilst taking SyreniRing. Additionally, patients who notice the symptoms/side effects or mood effects should seek immediate medical advice.

Pharmaceuticals
United Kingdom
03-08-2020
Pharmaceuticals
United Kingdom
03-08-2020

Accord-UK Ltd has informed us of an issue related to decommissioning of the above batch. Upon decommissioning at the pharmacy, there have been reports stating that when scanning the serialised 2D code, the status of packs may report as ‘EXPORT.’

Although there is no risk to product quality, any remaining stock should be quarantined and returned.

Pharmaceuticals
United Kingdom
03-08-2020
Pharmaceuticals
United Kingdom
03-08-2020

Brief description of the problem: Accord Healthcare Limited is recalling the above batch as a precautionary measure, due to the observation of precipitation in the solution in the same batch marketed in another country (Malta). No complaints or adverse reaction reports have been received by the company to date for the UK product.

Pharmaceuticals
United Kingdom
29-07-2020
Pharmaceuticals
United Kingdom
29-07-2020

Brief description of the problem: Kyowa Kirin Limited is recalling the above batch as a precautionary measure, due to the reports of double tablets in a single blister pocket. This was identified during reference sample inspection and there is a potential low risk of accidental double dosage.

Pharmaceuticals
United Kingdom
29-07-2020
Pharmaceuticals
United Kingdom
29-07-2020

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