Class 3 Medicines Recall: Omeprazole 20 mg/15 ml Oral Solution, Glenmark Pharmaceuticals Europe Ltd, EL(25)A/30

Glenmark Pharmaceuticals Europe Ltd is recalling a specific batch of Omeprazole Oral Solution as a precautionary measure due to an investigation following a customer complaint indicating precipitation and discoloration of the product in the bottles.

DMRC Number: DMRC-35139406

Company name: Glenmark Pharmaceuticals Europe Ltd

Product description: Omeprazole 20 mg/15 ml Oral Solution

PL: 25258/0383

Active ingredient: Omeprazole

SNOMED code: 42444511000001102

Details of the affected batch:

Brief description of problem: 

Glenmark Pharmaceuticals Europe Ltd is recalling a specific batch of Omeprazole Oral Solution as a precautionary measure due to an investigation following a customer complaint indicating precipitation and discoloration of the product in the bottles. A root cause has identified that this is a result of an inadequate assembly of the plunger stem and the cup which could lead to a premature mixing of the two components of the medicinal product

Advice to Healthcare Professionals: 

Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Advice to Patients: 

No further action is required by patients as this is a Pharmacy and Wholesaler level recall. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.

Patients who experience adverse reactions or have any questions about the 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 medical information enquiries please use the following options by phone +44 08004 580 383 or email medical_information@glenmarkpharma.com

For stock control enquiries please email orders.uk@glenmarkpharma.com

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