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Business Standard
2 days ago
- Business
- Business Standard
Aurobindo Pharma recalls over 4,600 bottles of painkiller in US market
Aurobindo Pharma's United States unit has initiated a recall of more than 4,600 bottles of a pain relief medication from the American market following consumer complaints about product quality, according to the US Food and Drug Administration's (USFDA) Enforcement Report. The product — Acetaminophen Tablets (325 mg) — is being recalled due to manufacturing deviations from Current Good Manufacturing Practices (cGMP), triggered by 'confirmed consumer complaints received with the observation of tablet discolouration (brown surface on tablets)', the US drug regulator mentioned. The Class-II recall of the drug, which is generally used for the relief of headaches, migraine, back pain, toothache, and muscular pain, was initiated by the Princeton-based subsidiary on May 22, the report mentioned. As per the USFDA classification, 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 probability of serious adverse health consequences is remote.' Reason for recall cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets) Product quantity 4,608 bottles Classification Class-II Aurobindo Pharma Q4 results In the fourth quarter of financial year 2024–25 (Q4FY25), Aurobindo Pharma Limited reported a marginal slump of 0.5 per cent in its net profit to ₹903 crore, compared to ₹907 crore in the same period last year. However, the revenue from operations hiked 10.6 per cent year-on-year (Y-o-Y) to ₹8,382 crore during the quarter, with growth seen across key business segments. Revenue from US formulations grew by 13.5 per cent Y-o-Y to ₹4,072 crore ($470 million), while Europe formulations posted a stronger growth of 17.2 per cent Y-o-Y to ₹2,147 crore (€236 million). Shares of Aurobindo Pharma last traded at ₹1124.75 apiece on the BSE at the close of the markets on Friday.
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Business Standard
22-04-2025
- Health
- Business Standard
Dr Reddy's, Lupin recall products in US due to manufacturing errors: USFDA
Dr Reddy's Laboratories and Lupin are recalling products in the US market due to labelling and manufacturing errors, respectively, according to the US health regulator. As per its latest Enforcement Report, US Food and Drug Administration (USFDA) said a US-based subsidiary of the Hyderabad-based drug major is recalling certain batches of a generic antiepileptic drug in the US market. Princeton-based Dr Reddy's Laboratories, Inc is recalling 4,010 bags of Levetiracetam 0.75 pc in Sodium Chloride Injection (1,000 mg/100 mL) in the US due to labelling mix up, USFDA said. "The infusion bag is incorrectly labelled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL," it added. The company has issued the Class 1 nationwide (US) recall on March 13 this year, the US health regulator noted. As per the USFDA, a Class I recall pertains to defective products that can cause serious health problems. In a separate filing, the US health regulator said that a US-based subsidiary of Mumbai-headquartered Lupin is recalling an antidepressant medication which used in the treatment of obsessive-compulsive disorder. Naples-based Lupin Pharmaceuticals Inc is recalling 2,724 bottles of clomiPRAMINE hydrochloride Capsules USP, 25 mg, due to "Failed Impurities/Degradation Specifications", USFDA said. The company initiated the Class II recall on April 18, it added.
Time of India
22-04-2025
- Health
- Time of India
Dr Reddy's, Lupin recall products in US due to labelling, manufacturing errors: USFDA
Dr Reddy's Laboratories and Lupin are recalling products in the US market due to labelling and manufacturing errors, respectively, according to the US health regulator. As per its latest Enforcement Report, US Food and Drug Administration (USFDA) said a US-based subsidiary of the Hyderabad-based drug major is recalling certain batches of a generic antiepileptic drug in the US market. Princeton-based Dr Reddy's Laboratories, Inc is recalling 4,010 bags of Levetiracetam 0.75 pc in Sodium Chloride Injection (1,000 mg/100 mL) in the US due to labelling mix up, USFDA said. "The infusion bag is incorrectly labelled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL," it added. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Join new Free to Play WWII MMO War Thunder War Thunder Play Now Undo The company has issued the Class 1 nationwide (US) recall on March 13 this year, the US health regulator noted. As per the USFDA, a Class I recall pertains to defective products that can cause serious health problems. Live Events In a separate filing, the US health regulator said that a US-based subsidiary of Mumbai-headquartered Lupin is recalling an antidepressant medication which used in the treatment of obsessive-compulsive disorder. Naples-based Lupin Pharmaceuticals Inc is recalling 2,724 bottles of clomiPRAMINE hydrochloride Capsules USP, 25 mg, due to "Failed Impurities/Degradation Specifications", USFDA said. The company initiated the Class II recall on April 18, it added.
