02.09.2020

GL Pharma GmbH - Oxylan 40mg prolonged-release tablets

Threat

GL Pharma is recalling a specific batch of Oxylan 40mg prolonged-release tablets due to out of specification results for dissolution during routine stability testing.

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Source of the alert

MHRA

The risk concerns products
MDR Number


MDR 158-08/20

Company Name

GL Pharma GmbH

Product description

Oxylan 40mg prolonged-release tablets, PL 21597/0064

Batch NumberExpiry DatePack SizeFirst Distributed

9F119A31/05/20245602/06/2020

Active pharmaceutical ingredient: oxycodone hydrochloride

Recommendations for consumers
Advice for healthcare professionals

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

Further information

For medical information enquiries please contact [email protected]

For stock control enquiries please contact [email protected]

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter.

NHS England and NHS Improvement Regional Offices are asked to forward this alert to community pharmacy contractors.

Alert details

Country of origin

-

Country for notification

United Kingdom

Category

Pharmaceuticals

Source of the alert

MHRA - Medicines & Healthcare products Regulatory Agency, www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

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