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 reference number
DMRC-35139406
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Ltd
Medicine Details
Omeprazole 20 mg/15 ml Oral Solution
PL: 25258/0383
Active ingredient: Omeprazole
SNOMED code: 42444511000001102
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 3230528 | 30/09/2025 | 14 | 29/01/2024 |
Background
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 for 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 for 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.
Additional 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
Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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