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Indian generics maker Sun Pharmaceutical is voluntarily recalling 41,127 bottles of the antidepressant venlafaxine HCl extended-release tablets over improper dissolution. Read More
Baxter is voluntarily recalling four lots of intravenous solutions in response to customer complaints of plastic and fiber particles in the product, its fourth recall this year related to particulates. Read More
After initially rejecting FDA’s authority, a Texas compounding pharmacy acceded to the agency’s request to cease production and recall all of its sterile products due to quality concerns. Read More
Hospira conducted its fourth recall in roughly two months due to contaminated products, leading to another quality headache for the injectables giant. Read More
The FDA asked healthcare professionals to watch out for drugs compounded by a Dallas-based pharmacy after a recent inspection revealed 22 lots of sterile drugs failed quality tests. Read More
The FDA has stepped up its enforcement of compounding pharmacy quality violations that occurred before a new law took effect that boosted agency powers, a move that some industry players contend is unjust. Read More
OTC drugmaker P&L Development received a Form 483 after investigators found the company didn’t test certain products for yeast and mold before release and for poor data integrity. Read More
An active pharmaceutical ingredient (API) maker was chided by the FDA for not keeping batch records, as well as not investigating out-of-specification results or performing full testing on products. Read More
A slew of leaky, deteriorating products, an insect infestation and poor complaint handling resulted in another Form 483 for beleaguered injectables giant Hospira. Read More
The new rule establishing FDA powers to destroy suspected counterfeit and adulterated drugs could cause shortages if the agency doesn’t protect against officials destroying needed excipients that get caught up in an import dispute, according to PhRMA. Read More
Over the next five years the FDA plans to increasingly coordinate its inspections and enforcement activities with its international counterparts. Read More