Orbit Pharma Limited is recalling a specific batch of Cyclizine Lactate 50 mg/ml Solution for injection as a precautionary measure due to Good Manufacturing Practice (GMP) deficiencies identified at the manufacturing site.
DMRC Number: DMRC- 39169596
Company name:Orbit Pharma Limited
Product description: Cyclizine Lactate 50 mg/ml Solution for injection - PL 56854/0020, SNOMED code: 45805811000001103, GTIN: 5061093630081
Details of the affected batch:
| Batch No. | Expiry Date | Pack Size | First Distributed |
| 2226016 | 31/12/2027 | 5 ampoules of 1ml | 19/05/2026 |
Background information:
Orbit Pharma Limited is recalling a specific batch of Cyclizine Lactate 50 mg/ml Solution for injection as a precautionary measure due to Good Manufacturing Practice (GMP) deficiencies identified at the manufacturing site. However, a Class 3 recall is being initiated out of an abundance of caution.
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 recall is being undertaken at a Pharmacy and Wholesaler level as a precautionary measure. 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 and information on this product, please email customerservice@novumgen.com or telephone +44 203 096 6496.
For stock control enquiries please email Stockcontrol@novumgen.com
To access the full recall/alert: Class 3 Medicines Recall: Orbit Pharma Limited, Cyclizine Lactate 50 mg/ml Solution for injection, EL(26)A/29