FAILED DISSOLUTION SPECIFICATIONS
Glenmark recalls 6,528 bottles of blood pressure drug in US
As per the USFDA, a Class II recall is initiated in a situation in which the 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.
Sun Pharma recalls around 55k bottles of generic medication in US
Sun Pharma is recalling approximately 55,000 bottles of a generic medication used to treat bowel disease in the US market. The recall is due to "Failed Dissolution Specifications," according to the US Food & Drug Administration (USFDA). The affected Mesalamine extended-release capsules were manufactured at Sun Pharma's Mohali plant and distributed in the US by Sun Pharmaceutical Industries Inc. Mesalamine capsules are indicated for treating mild to moderate ulcerative colitis. The US generic drug market was valued at around USD 115.2 billion in 2019, with Sun Pharma being a major player in the market.
Sun Pharma, Lupin recall drugs in US market: USFDA
Sun Pharmaceutical is recalling the affected lot that was produced at the drugmaker's Dadra-based facility. The company is recalling the lot due to "failed impurities/degradation specifications", the USFDA stated. USFDA stated that Mumbai-based Lupin is also recalling an unspecified number of penicillamine tablets in the US.
Zydus unit recalls 7,248 bottles of Oxybutynin Chloride tablets in US
New Jersey-based Zydus Pharmaceuticals (USA) Inc. is recalling the affected lot due to "Failed Dissolution Specifications", the USFDA stated. The lot was produced at Ahmedabad and distributed in the US by Zydus Pharmaceuticals (USA) Inc, the US health regulator stated.
Sun Pharma, Aurobindo recall drugs from US market
Sun Pharmaceutical Industries and Aurobindo Pharma are recalling products from the US market due to manufacturing issues. Sun Pharma's subsidiary is recalling 69,707 cartons of Cequa, used to treat dry eyes, for being "Subpotent." Aurobindo Pharma is recalling 9,890 bottles of Rasagiline Tablets, used for Parkinson's disease, due to "Failed dissolution specifications." The Indian pharmaceutical industry is the third largest in the world, with a market size of around USD 50 billion. India exported pharmaceuticals worth Rs 1,75,040 crore in 2021-22.
Sun Pharma recalls over 24K prefilled syringes of generic medication in the US
In its latest Enforcement Report, the US Food and Drug Administration (USFDA) noted that the Mumbai-based drug major is recalling 24,194 prefilled syringes of Fyremadel (ganirelix acetate) injection. The company is recalling the affected lot due to the presence of particulate matter, the USFDA said.
- Go To Page 1
Sun Pharma recalls over 34k bottles of generic drug in US due to manufacturing issues
Princeton (New Jersey) based Sun Pharmaceutical Inc is recalling the affected lot due to "Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory." The Mumbai-based drug major had produced the lot at its Halol-based manufacturing facility in Gujarat. The affected lot was later distributed in the market by its US-based unit.
Manufacturing issues led drug makers Glenmark, Sun Pharma, Dr Reddy's to recall products in US
As per the US health regulator, 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.
Dr Reddy's recalls 2,980 bottles of cholesterol lowering drug in US
As per the US Food and Drug Administration's latest Enforcement report, the Hyderabad-based drug major is voluntarily recalling the affected lots of the drug in 10 mg strength due to "failed impurities degradation specifications".
Lupin, Sun Pharma, Jubilant Cadista recall drugs in US market
According to the USFDA, the company is recalling the affected lot for being "Superpotent". The affected lot has been manufactured at Lupin's Mandideep plant in Madhya Pradesh and distributed in the US by Baltimore-based Lupin Pharmaceuticals Inc, the report stated.
Sun Pharma, Dr Reddy's, Aurobindo recall products in the US market
As per the latest Enforcement Report by the US Food and Drug Administration (USFDA), Sun Pharma is recalling Cequa ophthalmic solution, which is used to treat chronic dry eye.
Indian drug firms recall various products in US market
While Marksans Pharma is recalling diabetes drug, Zydus Pharmaceuticals (USA) is recalling drug which is used to reduce stomach acid.
Sun Pharma recalls 747 bottles of generic diabetes drug from the American market
As per the latest Enforcement Report of the US Food and Drug Administration (USFDA), Sun Pharmaceutical Industries is recalling the bottles of RIOMET ER (metformin hydrochloride for extended-release oral suspension) in the American market.
Cipla recalls 4,800 bottles of anti-HIV tablets from US
As per the latest Enforcement Report by the United States Food and Drug Administration (USFDA), the reason for the recall of the bottles is 'failed dissolution specifications'.
Karnataka governor bound by Supreme Court order to call Congress-JD(S)?
The foundation for limiting the governor's discretionary power was laid down by a seven-judge constitution bench of the SC in the landmark S R Bommai case in March1994.
Sensex climbs over 150 points, Nifty reclaims 10,200; Jet Airways cracks 4%
Among Sensex stocks, Tata Motors rose 1.65 per cent, while Airtel added 1.49 per cent.
Lupin, Cadila recall drugs in US Market
Zydus Pharmaceuticals USA Inc, arm of Cadila Healthcare, is also recalling 19,812 bottles of Paroxetine tablets in the strength of 30 mg from the US market.
Lupin, Cadila Healthcare recall drugs in US
Zydus Pharmaceuticals USA Inc, arm of Cadila Healthcare, is also recalling 19,812 bottles of Paroxetine tablets in the strength of 30 mg from the US market.
Lupin recalls 12,480 bottles of anti-depressant drug from US
Lupin Pharmaceuticals Inc is recalling 12,480 bottles of Paroxetine extended-release tablets in the strength of 12.5 mg manufactured by Lupin Ltd.
Dr Reddy's recalls 3.25 lakh cartons Cipla-made acne drug from US
The ongoing voluntary class II recall is nationwide in the USA and Puerto Rico, the United States Food and Drug Administration (USFDA) said.
Combiflam, D Cold and Cetrizine among 60 drugs marked 'substandard' in quality test
Specific batches of 60 drugs find mention in CDSCO's bulletin which describes these drugs as "not of standard quality/spurious/adulterated/misbranded".
Aurobindo Pharma, Cadila recall drugs from US market
Pantoprazole Sodium delayed-release tablets are used for treatment of erosive inflammation of the esophagus due to acid reflux.
2,839 bottles of Sun Pharma Inc being recalled in US
The ongoing nationwide voluntary recall by Nostrum Laboratories Inc for Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL is a class II recall, report said.
Apotex Inc recalls hypertension drug made by Indian arm
Apotex Inc has initiated a recall of 2,075 bottles of blood pressure treatment tablet 'Verapamil Hydrochloride' manufactured by Bangalore based Apotex Research.
Sun Pharma, Wockhardt recall drugs from US market
Sun Pharma initiated voluntary recall of Bupropion Hydrochloride Extended-¬release Tablets USP (SR), while Wockhardt started recalling its Lisinopril Tablets USP.
Dr Reddy's recalls Rivastigmine Tartrate capsules of 1.5 mg strength from US
Dr Reddy's Laboratories (DRL) has initiated voluntary recall of Rivastigmine Tartrate Capsules of 1.5 mg strength from the USA market.
Dr Reddy's Laboratories recalls anti-seizure, hypertension drugs from US market
The firm has started recalling Divalproex Sodium extended-release tablets as it has failed dissolution tests.
Sun Pharma recalls 5,322 bottles of Ketorolac eye drop in US
Last month, the drug major had recalled 3,263 bottles of epilepsy drug in US market for failing "dissolution specifications".
Sun Pharmaceutical Industries recalls Venlafaxine Hydrochloride after failing a dissolution test
The recall was made by Sun Pharma’s US subsidiary Caraco Pharmaceutical Laboratories for drugs manufactured in the company’s Indian facility.
Load More