Ropivacaine Hydrochloride

Amneal Pharmaceuticals is recalling three lots of sulfamethoxazole/trimethoprim tablets because of microbial contamination. The generic antibiotic is commonly used to treat urinary tract infections. Amneal Pharmaceuticals is recalling three lots of sulfamethoxazole/trimethoprim tablets because of microbial contamination that caused black spots to appear on the medication, according to a report from a customer.The New Jersey-based generics manufacturer has issued a U.S. recall of three lots of the 400-mg/80-mg tablets that may be contaminated with Aspergillus, a fungus that can cause life-threatening infections, especially for those with underlying immunosuppressive conditions, the FDA said.The recall is to the customer level, with notifications underway through UPS. The company has asked wholesalers, distributors and retailers to notify their customers of the recall and provide instructions on how to contact Amneal for the return of the products and for reimbursement information.Amneal has not received any related reports of adverse events, injuries or illnesses, the FDA said.The affected lots were shipped to distributors and wholesalers between Dec. 4, 2024, and May 15. All bottles have an expiration date of June 2027.Sulfamethoxazole/trimethoprim is packaged in bottles that contain 100 or 500 tablets. Two of the lots were 100-tablet bottles. Those lot numbers are AM241019 and AM241020. The other lot is 500-tablet bottles, with the AM241019A identifier. Sulfamethoxazole/trimethoprim is a combo medication commonly used for urinary tract infections. It is also used to treat middle ear infections, bronchitis, enteritis and traveler's diarrhea. Twenty years ago, Amneal gained approval to produce the generic version of the combo, which was originally brought to the market by Roche as Bactrim in 1969.The recall comes six weeks after Amneal recalled two lots of ropivacaine hydrochloride injection, with the warning that the anesthetic could contain inert “fibers” that leeched into the product from its IV bag, according to the FDA.In March 2024, the company also recalled four lots of generic vancomycin hydrochloride after a manufacturing error may have resulted in overfilled bottles.

SAN DIEGO, May 21, 2024 /PRNewswire/ -- Cali Biosciences Co., Ltd. (hereinafter referred to as "Cali Biosciences"), a biotechnology company dedicated to the research and development of innovative drugs, announced publication of "CPL‑01, an investigational long‑acting ropivacaine, demonstrates safety and efficacy in open inguinal hernia repair" in the scientific journal Hernia. The article's authors are Hanghang Tommy Xu, John Zimmerman, Todd Bertoch, Lee Chen, PJ Chen, and Erol Onel. "Recognition of the importance of these results by an esteemed journal such as Hernia is an important moment for Cali Biosciences," commented lead author, Dr. Tommy Xu. "In this study, our investigational drug CPL-01 out-performed not only placebo, but also standard of care Naropin®, with a clinically meaningful decrease in pain over 72 hours despite using half the opioids." Dr. Erol Onel, the Chief Medical Officer of Cali Biosciences US, LLC, agreed: "While there are several long-acting local anesthetics based on bupivacaine currently available, CPL-01 is based on ropivacaine, which is believed to be safer." The study's lead PI, Dr. Todd Bertoch, reiterated the safety of CPL-01, recounting the lack of serious adverse events in the dose advanced to Phase 3 and agreeing that "the advantages of a more effective and safer long-acting local anesthetic are obvious, and the ability to keep patients out of severe pain and towards an opioid-free recovery benefits society, the hospital systems, and of course the patients themselves." PJ Chen, the CEO of Cali Biosciences, emphasized that "along with our soon-to-be published successful Phase 2 bunion study, these results are incredibly encouraging and we are hopeful that our Phase 3 results will be as successful, leading to positive news from the regulatory authorities. When combined with our other pipeline products in the peri-operative space, Cali Biosciences is positioned to be a leader in this area with a suite of products that could help serve doctors and patients around the world." The publication may be accessed here: CPL-01, an investigational long-acting ropivacaine, demonstrates safety and efficacy in open inguinal hernia repair | Hernia (springer.com). About CPL-01 CPL-01 is a sustained-release injectable formulation of Naropin® (ropivacaine hydrochloride). Ropivacaine is a member of the amide class of local anesthetics indicated for the production of local or regional anesthesia for surgery and acute pain management. Naropin® injection is approved for local or regional anesthesia for surgery and for acute pain management. However, because of the short duration of effect of the traditional Naropin®, infusion by catheter is required if protracted local analgesia is needed for postoperative pain management. Based on the formulation of Naropin®, Cali Biosciences has applied PG-Depot, a versatile drug delivery platform, in developing CPL-01 to prolong the duration of analgesic effect at local site after a single local administration. About Cali Biosciences Cali Biosciences Co., Ltd. was established in Cayman Islands in 2021. Cali Biosciences US, LLC was established in San Diego in 2016, and later Cali Biosciences built its global headquarter in Shenzhen. Cali Biosciences is a biotechnology company dedicated to the research and development of pain management drug candidates based on its drug delivery platforms and other patented technologies, with a view to extending the coverage to manufacturing and commercialization of the pharmaceutical products it develops. The product pipeline of Cali Biosciences currently focuses on non-opioid post-operative pain management including analgesia, anesthesia, sedation, and control of inflammation. Cali Biosciences is committed to responding to unmet medical needs and serving patients and medical professionals around the world. SOURCE Cali Biosciences