A medicine millions of parents trust for their children is being recalled, and it's raising new questions about the safety of drugs made overseas.
Major recall of children's ibuprofen: The troubling track record of its India-based makerChildren's Ibuprofen Oral Suspension 100mg, sold in 4-ounce bottles, made by Strides Pharma and manufactured for Taro Pharmaceuticals USA.
This is a Class II recall, meaning it could cause temporary or medically reversible health problems. We have repeatedly inquired with the FDA regarding where the products were sold, but have not received a response.For our team, the story goes beyond a single recall. It points back to a system we've been investigating for years: foreign-made drugs, posing a real risk to patients, from plants that operate with almost no oversight and no consequences when something goes wrong.We traced the manufacturer of the products back to India It's a company familiar to former FDA inspector Peter Baker, who spent years performing inspections at plants in India. "I had visited that site years ago and found some pretty egregious conditions related to manufacturing of sterile products," he told us.revealed a Strides manufacturing facility had "no scientific rationale or data" to support its testing methods, and couldn't provethat its drugs were of the "strength, quality and purity" they represented.to another Indian Strides facility when the FDA found critical records for US drug products in a 55-gallon drum in a scrap yard, including documents dated and trashed just seven days prior to the scheduled inspection.Baker said it's no accident that records critical to FDA inspectors' evaluations are being trashed. "When they're discarding the records, when they make those release decisions, it's likely being made on unreliable data. So the quality of the products being released from the sites that are engaging in those practices are unknown," Baker said. The last inspection of the plant tied to the recall was in 2022. We know problems were identified, but the FDA report that details the results of that inspection is missing from the agency's database. We've filed a public records request to find out more, but it's evidence of a transparency gap for a company with a troubled history.I'll be honest with you, if this was in the US, folks would likely be prosecuted for this," said Peter Baker. "But because the company is not based here in the US, that's not possible. And so it's just sad that this egregious behavior can occur and it largely goes unpunished.The US depends on India for nearly half of its generic drug supply, but inspections overseas are limited and Baker said drugs are often made at facilities off the FDA's radar, and sometimes plants with a history of problems continue making drugs for American patients. The Strides facility that made the recalled children's ibuprofen, which hasn't been inspected for four years, received FDAStill, it's unclear exactly what drugs are being supplied by Strides, because transparency measures haven't been put into place.that would require labels to disclose where a drug is made, and told us they are open to including quality scores in future requirements that would inform consumers about the track record of a company."Transparency about where our drugs are made and coming from isn't necessarily yet in legislation," Baker said. "So it's difficult for a consumer to understand, first of all, where is my medicine coming from? And second of all, what is the reputation of this company that is making my medicines that I'm about to administer to a child? That really needs to change." Baker told us it's likely, given the history of the facility, that additional products could have contamination issues. "When you have a quality system failure, generally it affects all the products at that site and maybe even that whole network is manufacturing," he said. Strides' website boasts a "culture of accountability," ensuring high standards for safety and efficacy.Please provide a comment about the recall, including how Strides is actively following up on complaints about this medication.Do you anticipate further recalls?BE THE FIRST TO COMMENTMore than a decade after Washington legalized recreational cannabis, a new survey suggests many clinicians are increasingly worried about the mental-health riskA Bellevue, Washington, tax preparer who built a client base among tech workers was convicted of assisting in the creation of false tax returns, federal prosecuA person is dead after being pulled from the water at Green Lake, according to the Seattle Fire Department.A weakness in the system used to detect improper payments in subsidized child care contributed to an estimated $37M in questionable payments.Gov. Bob Ferguson has signed the Driver Privacy Act, Senate Bill 6002, into law, creating new statewide rules for automated license plate readers, cameras commo
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