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  • Sun Pharma, Dr Reddy's...

Sun Pharma, Dr Reddy's Labs, Aurobindo recall products in US over manufacturing issues

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-05-20T12:50:22+05:30  |  Updated On 20 May 2024 12:50 PM IST
FDC recalls over 60000 bottles of Timolol Maleate Ophthalmic Solution  in US
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New Delhi: According to the latest Enforcement Report from the US Food and Drug Administration (USFDA), pharmaceutical companies Dr Reddy's Laboratories, Sun Pharma, and Aurobindo Pharma are recalling products from the US market over manufacturing issues.

Dr Reddy's Laboratories is recalling close to 20,000 cartons of a medication used to control blood phenylalanine levels in adults and children.

Princeton (New Jersey) based Dr Reddy's Laboratories, Inc, is recalling Javygtor (sapropterin dihydrochloride) Powder for Oral Solution (100mg) due to it being a "Sub-potent Drug", USFDA stated.
The company is also recalling another lot of sapropterin dihydrochloride for the same reason, it added. The USFDA said the drug maker initiated the Class I recall in the US on April 8 this year.
As per the US health regulator, a Class I recall pertains to defective products that can cause serious health problems.
The USFDA said Sun Pharma is recalling 11,016 vials of Amphotericin B Liposome for Injection, used to treat fungal infections, in the US market.
The company's US-based arm initiated the Class II recall on April 19 this year due to "Out of specification for assay", the USFDA stated.
Similarly, "Aurobindo Pharma is recalling 13,605 bottles of Clorazepate Dipotassium Tablets (3.75 mg and 7.5 mg), used to treat anxiety, in the American market. The company's US-based arm is recalling the affected lot due to "Discoloration: Dotted and yellow spots on tablets", USFDA stated.
The company initiated the Class II recall on April 24 this year.
The USFDA stated that another drug firm FDC Ltd is recalling 3,82,104 units of Timolol Maleate Ophthalmic Solution, used to treat glaucoma, in the American market.
The Aurangabad (Maharashtra)-based drug firm is recalling the affected lot due to "Defective Container".
As per the USFDA, a Class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The US generic drug market, estimated to be around USD 115.2 billion in 2019, is the largest market for pharmaceutical products.

Read also: Dr Reddy's recalls six lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg over sub potency

dr reddys labssun pharmaaurobindo pharmarecallUSFDAjavygtorsapropterin dihydrochlorideamphotericin B liposomefungal infectionclorazepate dipotassium tabletsanxietyFDCtimolol maleate ophthalmic solutionglaucoma
Source : with inputs
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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