Class 4 Medicines Defect Notification: Relonchem Limited, Gabapentin Relonchem 50mg/ml Oral Solution, EL(26)A/31

Relonchem Limited have informed the MHRA that particles have been observed inside some bottles of Gabapentin Relonchem Oral Solution, identified through a customer complaint.

DMRC Number: DMRC-38460232

Company name:Relonchem Limited

Product description: Gabapentin Relonchem 50mg/ml Oral Solution - PL: 20395/0360, SNOMED code: 45344311000001104, GTIN: 5055144203362

Details of the affected batches:

Background information: 

Relonchem Limited have informed the MHRA that particles have been observed inside some bottles of Gabapentin Relonchem Oral Solution, identified through a customer complaint. The product storage instructions state: “Do not refrigerate or freeze. Do not store above 25°C.”

The investigation by Relonchem Limited has confirmed that these particles are formed due to crystallisation of the preservatives present in the product. The particles may develop if the product is stored at lower temperatures. These particles do not affect the potency of the formulation and the preservative levels remain sufficient in tested samples. Relonchem Limited consider the specific batches remain safe to administer to the patients.

Due to this product being critical to supply, the product batches are not being recalled.

Advice to Healthcare Professionals: 

• check the existing stock within your possession and identify if any of the Gabapentin Relonchem 50mg/ml Oral Solution batches listed above are impacted by this issue. The visual check should be done at the point of dispensing or administration. Please note that in addition to dispensaries, this may include clinics, wards and any other relevant locations
• ensure that the bottles are checked prior to dispensing for any visible crystals and return the bottles through your usual process if crystals are identified. For ease of checking presence of crystals, the bottles may be gently rotated once or twice
• the product should be stored according to the storage instructions (do not store above 25°C) and ideally the product should not be stored below 15°C
• if Gabapentin 50 mg/mL Oral Solution is being used for administration via feeding tubes (NG/PEG), alternate formulations should be considered, as there is a potential for obstruction of feeding tubes. Clinical judgement may be required for individual cases. More advice can be sought from Relonchem Limited via the contact details in this notification
• if there are any concerns raised by patients, they should be advised to contact a healthcare professional to obtain a new bottle but should not stop taking the medication unless directed by their physician

Healthcare professionals are advised to review the information contained within this notification and take this into account when dispensing this product.

Advice to Patients: 

Patients who have this medication at home should follow the storage instructions on the label. The product storage instruction state: Do not refrigerate or freeze. Do not store above 25°C.

Gabapentin 50 mg/mL Oral Solution should be stored at room temperature (below 25°C) and ideally above 15°C to prevent crystallization. If patients observe particles in the solution or there are any concerns, patients are advised to seek advice from a healthcare professional.

Never stop taking medicines such as gabapentin without medical advice. Suddenly stopping a medicine used for epilepsy, may cause your seizures to start again or happen more often or last longer than before. Suddenly stopping gabapentin when used for pain may impact your pain control.

Patients who have any additional concerns related to this information should contact their pharmacist in the first instance.

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Company contacts for further information: 

For all medical information enquiries and information on this product, please email medicalinformation@relonchem.com, or telephone 0151 556 1860. 

For stock control enquiries please email info@relonchem.com, or telephone 0151 5561 860.

To access the full recall/alert: Class 4 Medicines Defect Notification: Relonchem Limited, Gabapentin Relonchem 50mg/ml Oral Solution, EL(26)A/31