Lupin Pharmaceuticals Recall: Lupin is a global drugmaker. Its U.S. office must cancel two batches of Tydemy, an estrogen-progestin oral contraceptive. The 12-month security evaluation yielded unexpected findings. This disturbed corporate and medical staff.
L200183, the damaged batch, has less ascorbic acid and more impurity than predicted. The U.S. Food and Drug Administration (FDA) advised Lupin Pharmaceuticals Inc. to act swiftly since these issues might affect product performance.
Lupin Pharmaceuticals Inc. said the voluntary recall was necessary to safeguard customers’ health and demonstrated the company’s dedication to quality. The memory followed the company’s July 29 FDA notificationthe impacted parcels sold between June 3, 2022, and May 31, 2023.
Contraceptives help millions plan their families and regulate their hormones. Any deviation from standards must be investigated immediately to ensure these drugs are safe and effective.
Lupin has proven successful in the U.S. The parent company stated the FDA approved their brief new drug application for Turqoz (Norgestrel and Ethinyl Estradiol Tablets USP) 0.3 mg/0.03 mg one day before the recall. This new drug is Wyeth Pharmaceuticals’ Lo/Ovral-28 (Norgestrel and Ethinyl Estradiol Tablets) 0.3 mg/0.03 mg. Lupin’s Pithampur factory may now make the product.
Novel Laboratories Inc., a wholly owned Somerset, New Jersey firm, has received FDA clearance for its abbreviated new drug application for Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil). Hill Dermaceuticals Inc. makes Derma-Smoothe/F.S. Topical Oil, 0.01% (Scalp Oil). However, this oil is produced by a separate company. Lupin plans to have this product at its Somerset factory in the U.S.
Despite some positive developments, Lupin’s stock has suffered from Tydemy’s recall. The company’s BSE shares closed at 993.90. The memory reminds us that pharmaceutical work is challenging and quality control is crucial.
Pharmacists also stress the need to monitor a drug’s safety and quality throughout its life. The steady evaluation approach examines how temperature, humidity, and light affect medication product quality over time. Understanding these alterations helps ensure medication efficacy and safety.
Lupin’s swift recall and vow to be transparent with the FDA and the public demonstrate its desire to maintain consumer and regulatory confidence. Quick refunds and remedial actions demonstrate a commitment to patient safety above short-term profitability.
Lupin’s U.S. office promptly returned two Tydemy batches that failed the 12-month stability study. This tragedy momentarily obscured Lupin’s previous triumphs and demonstrated the company’s dedication to patient safety and willingness to act responsibly. Quality control and transparent communication are essential to maintain public health and trust as the pharmaceutical company evolves.
Our Reader’s Queries
What is the FDA warning on Lupin Pharmaceuticals?
Lupin, a pharmaceutical company, announced in November that it had halted production of drugs bound for the United States from its drug ingredients plant in Tarapur. The plant had been under scrutiny by the FDA, which requested that Lupin provide notification before resuming operations. This was not the first time Lupin had acknowledged issues at the facility, as it had previously reported the receipt of a notice from the FDA in September.
Which Lupin medicine is recalled?
Four lots of Quinapril Tablets are being voluntarily recalled due to the potential presence of N-Nitroso-Quinapril Impurity. The FDA provides a public service by posting announcements made by companies regarding recalls, market withdrawals, or safety alerts.
What blood pressure medication is being recalled 2023?
Amerisource Health Services has issued a recall for a batch of hydralazine hydrochloride tablets due to impurity concerns. The US Food and Drug Administration (FDA) Enforcement Report from October 11, 2023, revealed that the repackaged product failed to meet impurity specifications at the 12-month time point. This recall serves as a precautionary measure to ensure the safety and well-being of consumers.
Is Lupin Pharmaceuticals recall on metformin?
Lupin Pharmaceuticals Inc. has issued a voluntary recall for all batches of metformin hydrochloride extended release (ER) 500 mg and 1000mg tablets, as announced by the FDA on July 8, 2020. This recall is in response to potential contamination concerns. It is important for those taking this medication to check with their healthcare provider and follow the FDA’s recommendations.