27 Apr Rocephin 1G injection (1 vial with dry substance equivalent to 1g ceftriaxone + 1 ampoule water for injection 10ml)
| Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
| Roche products (Pty) LtdBuilding E, Hertford Office Park90 Bekker Road, Midrand
1686 |
R/20.1.1/46 |
B0757B04
|
31-03-2024 |
1 |
Mar-2021
|
Class I Type C |
1 July 2022 |
Reason for recall
The products are being recalled due to quality defect: Pinholes were found on the 10ml Water for Injection that is co-packaged with the Rocephin 1g Vial. These pinholes are melting defects located at the top of the ampoule head and surrounded by concavity.
Advice to HCPs/Distributors/Public:
Affected stock has been blocked for distribution and the applicant requested their clients for immediate return of the affected batch of Rocephin 1G Vial pack to the
supplying wholesaler or distributor for full credit.
Proposed action taken and its urgency: SAHPRA approved recall letter distributed to all distribution points, recall 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.