Cyclizine Lactate 50 mg/ml Solution for injection
What this means
The MHRA has issued a medicines recall or defect notification. Class 1: risk to life, immediate recall. Class 2: may cause mistreatment or harm, recall within 48 hours. Class 3: unlikely to cause harm, recall within 5 days. Class 4 (defect notification): no recall, caution in use. The medicine remains licensed; only the listed batches are affected. Do not stop treatment without speaking to your doctor or pharmacist.
Class 3 recall · DMRC- 39169596
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| Cyclizine Lactate 50 mg/ml Solution for injection | PL 56854/0020 | cyclizine lactate | 5061093630081 |
Batches (expiry): 2226016 (31/12/2027)
Background: 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 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.