MHRA 发布 2 类药品召回：Rokshaw 以 Curaleaf Laboratories 名义经营的 Curaleaf Oil [FS] 10mg/ml THC、10mg/ml CBD（30ml），EL(26)A/13

Contents

1. DMRC reference number
2. Marketing Authorisation Holder
3. Medicine Details
   1. Curaleaf Oil [FS] 10mg/ml THC, 10mg/ml CBD (30ml)
4. Affected Lot Batch Numbers
5. Background
6. Advice for Healthcare Professionals
7. Advice for Healthcare Professionals to Provide to Patients
8. Additional information
9. Download document

DMRC reference number

DMRC- 38668711

Marketing Authorisation Holder

Rokshaw Limited Trading as Curaleaf Laboratories

Medicine Details

Curaleaf Oil [FS] 10mg/ml THC, 10mg/ml CBD (30ml)

MS 41467

Active ingredient: delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)

SNOMED code: N/A

GTIN: N/A

Affected Lot Batch Numbers

Background

Curaleaf Laboratories have informed MHRA of a confirmed stability study failure where the THC content is below the acceptable level in Curaleaf Oil [FS] 10mg/ml THC 10mg/ml CBD (30ml).

The above batches of Curaleaf Oil [FS] 10mg/ml THC 10mg/ml CBD (30ml) are being recalled out of an abundance of caution.

Advice for Healthcare Professionals:

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

Advice for Healthcare Professionals to Provide to Patients:

No action is required by patients, the recall is at the wholesaler and pharmacy level.

Patients should continue to use the product as instructed by their healthcare professional. No adverse events have been received for these batches of products. If patients have any questions about this medication, you should speak to their healthcare professional in the first instance.

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 all medical information enquiries and information on this product, please email [email protected], or telephone +44 0191 7431007.

For stock control enquiries please email [email protected],  or telephone +44 0191 7431007.

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

[email protected]

Download document

Class 2 Medicines Recall: Rokshaw Limited Trading as Curaleaf Laboratories, Curaleaf Oil [FS] 10mg/ml THC, 10mg/ml CBD (30ml), EL(26)A/13