Latest news with #AcetaminophenTablets
The Hindu
17 hours ago
- Health
- The Hindu
Aurobindo recalling over 4,600 bottles of pain relieving tablets in U.S.
Generic drugmaker Aurobindo Pharma is recalling 4,608 bottles of pain relieving drug Acetaminophen Tablets, 325 mg, in the U.S. They are 100-count bottles and being recalled due to deviations from current Good Manufacturing Practices (cGMP), the U.S. Food and Drug Administration (U.S. FDA) said. Specially it is 'due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets),' the regulator said in its latest enforcement report. It is a voluntary recall and initiated by Aurobindo Pharma USA Inc., a subsidiary of the Hyderabad-based drugmaker, on May 22.
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Business Standard
a day 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.
Time of India
a day ago
- Health
- Time of India
Aurobindo Pharma recalls 4,608 bottles of pain relieving drug in US
Aurobindo Pharma is recalling over 4,600 bottles of a pain relieving drug in the US market due to manufacturing issues, according to the US health regulator. A US-based unit of the Hyderabad-based drug major is recalling 4,608 bottles of Acetaminophen Tablets (325 mg) in the US due to cGMP (Current Good Manufacturing Practices) deviations, the US Food and Drug Administration (USFDA) said in its latest Enforcement Report. The affected lot is being recalled "due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets)", it added. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like War Thunder - Register now for free and play against over 75 Million real Players War Thunder Play Now Undo The medication is used to relieve headaches, migraine, toothache, back pain and muscle pain, among others. Princeton-based Aurobindo Pharma USA Inc initiated the Class II recall on May 22 this year. Live Events 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. Shares of Aurobindo Pharma on Friday were trading 0.08 per cent up at Rs 1,124.05 apiece on BSE.
