27 Apr Ketamine 50 mg/1 ml Fresenius (Ketamine Hydrochloride)
|
Company name & Address: |
Registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Recall date |
| Fresenius Kabi Manufacturing South Africa (Pty) Ltd. 6 Gibaud Road, Korsten, Gqeberha, 6020, South Africa |
Y/2.1/273 |
90SKB230 |
September 2027 |
10 units per carton |
21 December 2023 |
Class II Type C |
14 June 2024 |
Reason for recalls
This precautionary recall is initiated due to potential glass cracks in the vial neck, limited to this batch.
Advice to HCPs/Distributors/Public
We request that you refrain from using and selling any of the affected batch of Ketamine 50 mg/1 ml Fresenius Injection and return the stock to your supplying warehouse or distributor, along with the relevant invoice, with immediate effect. Fresenius Kabi South Africa (Pty) Ltd will credit all returned stock.
Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process was initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.