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Leaking Inhaler Valve Leads to Recall of Six Batches of Cipla’s Albuterol
There is a risk the inhaler wouldn’t provide the right dose.
Cipla US is voluntarily recalling six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) manufactured in November 2021. Albuterol is used treat patients with asthma and chronic obstructive pulmonary disease.
The recall is being made because of damage to a single inhaler (Batch Number - IB20056), where leakage was observed through the inhaler valve. There is a risk the inhaler wouldn’t provide the right dose.
The product is packaged in 17 ml plain aluminum aerosol canister integrated with dose counter coupled with plastic actuator and dust cap. The recalled product has NDC code of NDC-69097-142-60 and had an expiration date of November 2023. A list of the batch numbers can be found here.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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