This is a drug alert for March 2023 (Revised) listing drugs, medical devices, vaccines, and cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded.
The gazette specifically mentions one drug, DACILON 0.5 (Dactinomycin for Injection USP 0.5 mg), manufactured by Celon Laboratories Pvt. Ltd.
Key Changes
DACILON 0.5 (Dactinomycin for Injection USP 0.5 mg), batch number DMI22412/203AC22, with a manufacturing date of 11/2022 and expiry date of 11/2025, manufactured by Celon Laboratories Pvt. Ltd. is listed.
The reason for inclusion is that while the sample was declared as Standard Quality regarding Appearance & Assay by CDL, Kolkata as per Form-2 report no. 2-1/2023-SS/CC-169/715 dated 10.10.2023, it is subject to the outcome of further investigation.
Impact Analysis
Impact on Celon Laboratories Pvt. Ltd.
Financial impact due to potential recalls, legal fees, and loss of sales.
Suggested Action Items for Celon Laboratories Pvt. Ltd.
Communicate transparently with stakeholders, including regulatory authorities, healthcare professionals, and patients.
Impact on Healthcare Professionals
Potential need to consider alternative medications if concerns about the drug's quality persist.
Suggested Action Items for Healthcare Professionals
Report any suspected adverse events to the appropriate regulatory authorities.
Impact on Patients
Need to be vigilant for any unusual side effects or symptoms.
Suggested Action Items for Patients
Report any suspected adverse events to their healthcare provider and the appropriate regulatory authorities.
Key Entities Referenced
DACILON 0.5 (Dactinomycin for Injection USP 0.5 mg): A drug manufactured by Celon Laboratories Pvt. Ltd. that is subject to further investigation regarding its quality.
Celon Laboratories Pvt. Ltd.: The manufacturer of DACILON 0.5 (Dactinomycin for Injection USP 0.5 mg), located in Telangana, India.
CDSCO: Central Drugs Standard Control Organisation
CDL, Kolkata: Central Drugs Laboratory, Kolkata, which conducted the initial quality testing.
Form-2: A standard form related to drug testing and analysis.
Drug Alert for the Month of March – 2023 (Revised)
List of Drugs, Medical Devices, Vaccine and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of March–
2023 (Revised)
S.No Name of Batch No. Date of Date of Manufactured By Reason for Drawn By From Remarks
Drugs/medical Manufa Expiry failure (Name of
device/cosmetics cture the
Laboratory)
10. As per Form-2 (CDL, Kolkata)
Celon Laboratories
report no. 2-1/2023-SS/CC-
Pvt. Ltd., Plot No.2,
169/715 dated 10.10.2023, the
DACILON 0.5 ALEAP Industrial
subject sample declared as
(Dactinomycin DMI224 12/20 Estate, Appearance CDSCO CDL,
11/2025 Standard Quality in regard to
for Injection USP 3AC 22 Gajularamaram, & Assay Hyderabad Kolkata
the test for “Appearance &
0.5 mg) Medchal Dist.
Assay”, however, the same is
500090, Telangana
subject to outcome of further
State, India.
investigation.
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