
Lupin launches Loteprednol Etabonate Ophthalmic Suspension in US
Loteprednol Etabonate Ophthalmic Suspension, 0.5% is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.
It is also indicated for the treatment of post-operative inflammation following ocular surgery.
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Mint
a day ago
- Mint
Sun Pharma, Lupin, Dr Reddys recall products in US market
New Delhi, Domestic drug majors Sun Pharma, Lupin and Dr Reddy's Laboratories are recalling drugs in the US market due to manufacturing issues and product mix up, according to the US health regulator. As per the latest Enforcement Report of US Food and Drug Administration , the Mumbai-headquartered Sun Pharmaceutical Industries is recalling 5,448 bottles of a generic medication in the US. Princeton-based Sun Pharmaceutical Industries Inc is recalling the affected lot of Lisdexamfetamine Dimesylate capsules due to "Failed Dissolution Specifications", the US health regulator stated. The medication is used to treat attention deficit hyperactivity disorder . The drug firm initiated the Class II recall in the US on June 16 this year, it added. Another Mumbai-based drug maker Lupin is recalling 58,968 bottles of a generic combination medication used to treat high blood pressure. Naples-based Lupin Pharmaceuticals Inc is recalling Lisinopril and Hydrochlorothiazide tablets . The affected lot was manufactured at the company's Nagpur-based manufacturing facility. As per the USFDA, the company initiated the Class II recall on June 20 due to "Product Mix Up". This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg, the US health regulator stated. In another filing, the US health regulator said that Dr Reddy's Laboratories is recalling 1,476 bottles of Omeprazole Delayed-release capsules. The medication is used to treat certain stomach and esophagus problems. Princeton-based Dr. Reddy's Laboratories, Inc initiated the Class II recall on June 30, 2025, USFDA stated. The affected lot was produced at the company's Bachupally -based manufacturing facility. The recall is due to the presence of foreign tablets/capsules, USFDA said. It is due to the presence of foreign Divalproex Sodium extended-release 250mg tablets in a bottle of omeprazole capsules, it added. As per the USFDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.
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Business Standard
a day ago
- Business Standard
Sun Pharma, Lupin, Dr Reddy's recall products in US due to mfg issues
Domestic drug majors Sun Pharma, Lupin and Dr Reddy's Laboratories are recalling drugs in the US market due to manufacturing issues and product mix up, according to the US health regulator. As per the latest Enforcement Report of US Food and Drug Administration (USFDA), the Mumbai-headquartered Sun Pharmaceutical Industries is recalling 5,448 bottles of a generic medication in the US. Princeton-based Sun Pharmaceutical Industries Inc is recalling the affected lot of Lisdexamfetamine Dimesylate capsules (60 mg) due to "Failed Dissolution Specifications", the US health regulator stated. The medication is used to treat attention deficit hyperactivity disorder (ADHD). The drug firm initiated the Class II recall in the US on June 16 this year, it added. Another Mumbai-based drug maker Lupin is recalling 58,968 bottles of a generic combination medication used to treat high blood pressure. Naples-based Lupin Pharmaceuticals Inc is recalling Lisinopril and Hydrochlorothiazide tablets (USP 20mg/12.5mg). The affected lot was manufactured at the company's Nagpur-based manufacturing facility. As per the USFDA, the company initiated the Class II recall on June 20 due to "Product Mix Up". This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg, the US health regulator stated. In another filing, the US health regulator said that Dr Reddy's Laboratories is recalling 1,476 bottles of Omeprazole Delayed-release capsules. The medication is used to treat certain stomach and esophagus problems. Princeton-based Dr. Reddy's Laboratories, Inc initiated the Class II recall on June 30, 2025, USFDA stated. The affected lot was produced at the company's Bachupally (Telangana)-based manufacturing facility. The recall is due to the presence of foreign tablets/capsules, USFDA said. It is due to the presence of foreign Divalproex Sodium extended-release 250mg tablets in a bottle of omeprazole capsules, it added. As per the USFDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.


Time of India
a day ago
- Time of India
Sun Pharma, Lupin, Dr Reddy's recall products in US market due to manufacturing issues
Domestic drug majors Sun Pharma , Lupin and Dr Reddy's Laboratories are recalling drugs in the US market due to manufacturing issues and product mix up, according to the US health regulator . As per the latest Enforcement Report of US Food and Drug Administration ( USFDA), ), the Mumbai-headquartered Sun Pharmaceutical Industries is recalling 5,448 bottles of a generic medication in the US. Explore courses from Top Institutes in Please select course: Select a Course Category PGDM Operations Management MBA others Data Analytics Cybersecurity Public Policy Management Healthcare Design Thinking MCA Data Science Data Science Product Management Others Artificial Intelligence Degree Project Management Digital Marketing Technology Leadership CXO healthcare Finance Skills you'll gain: Financial Analysis & Decision Making Quantitative & Analytical Skills Organizational Management & Leadership Innovation & Entrepreneurship Duration: 24 Months IMI Delhi Post Graduate Diploma in Management (Online) Starts on Sep 1, 2024 Get Details Princeton-based Sun Pharmaceutical Industries Inc is recalling the affected lot of Lisdexamfetamine Dimesylate capsules (60 mg) due to "Failed Dissolution Specifications", the US health regulator stated. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like How Much Does It Cost to Rent a Private Jet - The Prices May Surprise You! Private Jet I Search Ads Learn More Undo The medication is used to treat attention deficit hyperactivity disorder ( ADHD ). The drug firm initiated the Class II recall in the US on June 16 this year, it added. Live Events Another Mumbai-based drug maker Lupin is recalling 58,968 bottles of a generic combination medication used to treat high blood pressure. Naples-based Lupin Pharmaceuticals Inc is recalling Lisinopril and Hydrochlorothiazide tablets (USP 20mg/12.5mg). The affected lot was manufactured at the company's Nagpur-based manufacturing facility. As per the USFDA, the company initiated the Class II recall on June 20 due to "Product Mix Up". This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg, the US health regulator stated. In another filing, the US health regulator said that Dr Reddy 's Laboratories is recalling 1,476 bottles of Omeprazole Delayed-release capsules. The medication is used to treat certain stomach and esophagus problems. Princeton-based Dr. Reddy's Laboratories , Inc initiated the Class II recall on June 30, 2025, USFDA stated. The affected lot was produced at the company's Bachupally (Telangana)-based manufacturing facility. The recall is due to the presence of foreign tablets/capsules, USFDA said. It is due to the presence of foreign Divalproex Sodium extended-release 250mg tablets in a bottle of omeprazole capsules, it added. As per the USFDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.