Urgent recall of 2 batches of Compost for oral suspension Zinnat Suspension 125mg
The Drug Administration of Vietnam (Ministry of Health) on May 9 issued an official letter to recall the batch of Compounds for oral suspension of Zinnat Suspension 125mg (Cefuroxime axetil 125mg).
Accordingly, 2 batches of Compound for oral suspension Zinnat Suspension 125mg with GDKLH number: VN-20513-17 including: Lot number 7S6A, expiry date 11/13/2022 and batch number 2P7N, expiry date 16/7/2022.
Two batches of the drug were manufactured by Glaxo Operations UK Limited (UK), GlaxoSmithKline Pte., Ltd. (Singapore) registered, imported by Zuellig Pharma Vietnam Co., Ltd.
Previously, on April 22, the representative office of GlaxoSmithKline Pte Ltd in Ho Chi Minh City issued a report on routine stability testing. According to this report, the drug sample did not meet the quality standards in terms of organoleptic criteria, moisture content, and related impurities – corresponding to level 2 violations.
Therefore, this unit reported to the Drug Administration to recall the drug on a voluntary basis at the user level.
The Drug Administration of Vietnam has announced a nationwide recall of the above batches of Zinnat Suspension 125mg.
This Department requires Zuellig Pharma Vietnam Co., Ltd. to coordinate with drug suppliers and distributors within 2 days from today to send recall notices to wholesalers, retailers, and users of drug batches. and recall the entire batch of drugs that do not meet the above quality standards.
Within 18 days, this unit must send a recall report to the Drug Administration of Vietnam. The recall dossier includes the quantity imported, the date of importation, the quantity recalled, and evidences on the implementation of the recall at the wholesalers, retailers, and users who have purchased the drugs as prescribed.
The Departments of Health of the provinces, cities and branches of health are also requested to notify drug-using and trading establishments to recall the batch of drugs that fail to meet the above-mentioned quality; publish information about the drug recall decision on the Department’s website; inspect and supervise the units implementing this notice; handle violators according to current regulations; report to the Drug Administration of Vietnam and relevant authorities.
Particularly, the Department of Health of Ho Chi Minh City is required to inspect and supervise Zuellig Pharma Vietnam Co., Ltd. to recall and handle recalled drugs according to regulations.
Zinnat Suspension 125mg Oral Suspension is indicated for the treatment of infections caused by susceptible bacteria such as upper respiratory tract infections, urogenital infections, skin and soft tissue infections…
Thanh Hien
at Blogtuan.info – Source: vietnamnet.vn – Read the original article here
[url=https://www.tcspharmaceuticals.com/pro/Daptomycin_103060-53-3_dose_class_side_effects_and_price.html]daptomycin[/url], sold under the brand name cubicin among others, is a lipopeptide antibiotic used in the treatment of systemic and life-threatening infections caused by gram-positive organisms. it is a naturally occurring compound found in the soil saprotroph streptomyces roseosporus. its distinct mechanism of action makes it useful in treating infections caused by multiple drug-resistant bacteria.
daptomycin was removed from the world health organization’s list of essential medicines in 2019. the world health organization classifies daptomycin as critically important for human medicine.
medical uses
daptomycin is indicated for use in adults in the united states for skin and skin structure infections caused by gram-positive infections, s. aureus bacteraemia, and right-sided s. aureus endocarditis. it binds avidly to pulmonary surfactant, so cannot be used in the treatment of pneumonia. there seems to be a difference in working daptomycin on hematogenous pneumonia.
adverse effects
common adverse drug reactions associated with daptomycin therapy include:
cardiovascular: low blood pressure, high blood pressure, swelling
central nervous system: insomnia
dermatological: rash
gastrointestinal: diarrhea, abdominal pain
hematological: eosinophilia
respiratory: dyspnea
other: injection site reactions, fever, hypersensitivity
less common, but serious adverse events reported in the literature include
hepatotoxicity: elevated transaminases
nephrotoxicity: acute kidney injury from rhabdomyolysis
also, myopathy and rhabdomyolysis have been reported in patients simultaneously taking statins, but whether this is due entirely to the statin or whether daptomycin potentiates this effect is unknown. due to the limited data available, the manufacturer recommends that statins be temporarily discontinued while the patient is receiving daptomycin therapy. creatine kinase levels are usually checked regularly while individuals undergo daptomycin therapy.
in july 2010, the fda issued a warning that daptomycin could cause life-threatening eosinophilic pneumonia. the fda said it had identified seven confirmed cases of eosinophilic pneumonia between 2004 and 2010 and an additional 36 possible cases. the seven confirmed victims were all older than 60 and symptoms appeared within two weeks of initiation of therapy.