Amneal Pharma recalling three lots of urinary tract infection tablets in U.S.
The recall is to the consumer level as the tablets may exhibit black spots on the tablet surface due to microbial contamination. The observance of black spots was reported in a product quality complaint, U.S. Food and Drug Administration said on the nationwide recall announcement of Amneal Pharmaceutical LLC.
Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg is packaged in 100 tablet count and 500 tablet count bottles. The recall pertains only to the 400 mg/80 mg strength and the three lots. Amneal Pharmaceuticals has received no reports of adverse events, illnesses or injuries related to this recall, the U.S. FDA said.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Hindustan Times
6 hours ago
- Hindustan Times
FDA recalls butter across US: What Class II warning means, which product has been recalled
Beware while buttering your toasts as the U.S. Food and Drug Administration (FDA) recently escalated a nationwide butter recall to Class II, a higher risk level. The butter recall for 64,800 lbs (or 1,800 cases) was initially issued by Bunge North America Inc. Image for representation(Pixabay) The risk classification was raised by the FDA on Wednesday, July 30. Why was butter recall issued and who is to blame? The butter recall for 64,800 lbs (or 1,800 cases) was issued by Bunge North America Inc, which is based out of Chesterfield, Missouri. The product that has been recalled is its European Style Butter Blend 1 lb. The voluntary recall came on July 14, and has now been escalated by the government entity. The company said it was recalling the product because milk was undeclared and not listed on the product label. The lot code number for the butter is 5064036503. Milk is one of the nine food allergens as per the FDA site. Food-related allergies can vary in symptoms ranging from face and lip swelling to vomiting. However, there is also the risk of severe reactions like anaphylaxis, where the immune system could release a 'flood of chemicals' which could make a person go into shock and end up being fatal for them, Mayo Clinic said. As per the FDA, they enforce regulations to avoid such situations and they said there are 'more specific labeling requirements' for foods that can cause allergies and other hypersensitive reactions. What does FDA's Cass II warning mean? As per the FDA site, a Class II recall indicates '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'. They advised people, that if anyone has consumed the product and starts to feel something is not right, they should 'stop eating the food immediately, evaluate the need to use emergency medication (such as epinephrine) and seek medical attention.'
Mint
14 hours ago
- Mint
FDA recalls over 64,000 pounds of butter over milk allergen risk; warning issued for adverse health consequences
The U.S. Food and Drug Administration (FDA) has issued a recall for more than 64,000 pounds of butter, citing concerns over undeclared milk allergens that could cause adverse health effects in consumers. According to a July 14 alert, Bunge North America, a food ingredient company based in Chesterfield, Missouri, voluntarily recalled 1,800 cases of its NH European Style Butter Blend. The affected butter was distributed across 12 centres in the United States and one in the Dominican Republic. On July 31, the FDA classified the recall under its Class II risk category—the agency's second-highest warning level—stating that 'consumption could pose temporary or medically reversible adverse health consequences.' The issue lies in the product's labelling, which failed to declare the presence of milk, a known allergen that can cause reactions in sensitive individuals. No injuries or illnesses have yet been reported in connection with the recall. USA TODAY has reached out to Bunge North America for comment regarding the oversight and recall procedures but has not yet received a response. Bunge North America is a major player in the agribusiness and food ingredient sector, producing and distributing items such as corn, wheat, rice, soybeans, and feed peas, alongside cooking ingredients like butter blends. Consumers who may have purchased the affected product are advised to check for the NH European Style Butter Blend and discontinue use immediately if any undeclared allergen risks apply. The FDA urges consumers with milk allergies or sensitivities to exercise caution and monitor product recall alerts closely.
The Hindu
24-07-2025
- The Hindu
Lupin gets U.S. FDA nod for two generic diabetes drugs
Generic drugmaker Lupin has received U.S. Food and Drug Administration approval for its abbreviated new drug applications for Liraglutide Injection single-patient-use prefilled pens and Glucagon for injection vials. Both the products will be manufactured at the company's injectable facility in Nagpur, Lupin said. Liraglutide injection 18 mg/3 mL (6 mg/mL) single-patient-use prefilled pen is bioequivalent to Novo Nordisk's Victoza injection and had an estimated annual sale of $458 million in the U.S, the company said citing IQVIA MAT May numbers. The drug is indicated to improve glycaemic control in adults and children, aged above 10 years, with type 2 diabetes mellitus. Glucagon for Injection USP, 1 mg/vial, is bioequivalent to Eli Lilly and Company's Glucagon for Injection, 1 mg/vial. It is indicated for treatment of severe hypoglycaemia in paediatric and adult patients with diabetes mellitus and as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. It had an estimated annual sale of $124 million in the U.S. Chief Scientific Officer Shahin Fesharaki said the two products are a meaningful enhancement to the company's portfolio.
