27 Apr Azacitidine DRL 100mg Lyophilized powder for Injection (Azacitidine)
| Company name & Address: |
registration number |
Batch number |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
| Dr. Reddy’s Laboratories Limited, Chemical Technical Operations, Unit- I, Plot No. 137,138, 145
& 146 |
51/26/0144 |
H210418 |
Mar/2023 |
Vial: 30ml |
2021/10/06 |
Class III Type C |
11 January 2022 |
Reason for recall
The products are being recalled due to quality defect: The company initiates an immediate recall of the following batches of the products, as listed above, following detection during periodic re-qualification of VHP (Vaporized Hydrogen Peroxide) decontamination cycle executed at Dr. Reddy’s Formulation Unit-07, for the Filling Isolator Equipment PR-E235 & PR-E3 l 8 (Zone 1 + 3) in Line-1, Biological Indicator (BI) failure observed at locations pertaining to ISl0- Lyo loading & unloading area. Root Cause: From the investigation it was concluded that the failure of VHP requalification run was due to improper distribution of the vaporized hydrogen peroxide vapours inside the isolator. The probable reason for the failure was due to the presence of polybags in the VHP distribution lines of Isolator IS10.
Advice to HCPs/Distributors/Public:
The action was initiated to halt and facilitate return of any potential product available at wholesale level. Distribution points will be requested to return the impacted product via their routine distribution channel to receive credit for the relevant quantities returned. All product impacted in South Africa was quarantined at the warehouse facility and reconciled against the quantity distributed.
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.