NP Thyroid Recall Update: FDA Publishes Warning Letter to Acella
As we reported in previous posts here and here, in May 2020 Acella Pharmaceuticals recalled 13 lots of NP Thyroid after finding the product was superpotent and posed significant risks to consumers. Following the recall, the FDA sent a strongly worded Warning Letter to Acella that laid out in detail the flaws in Acella’s manufacturing process that led to the recall.
The FDA said that Acella’s “methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to [current good manufacturing practices (CGMP).]” The FDA chastised Acella for failing to “establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that . . . drug products conform to appropriate standards of identity, strength, quality, and purity.” Likewise, the FDA said that Acella’s NP Thyroid products are “adulterated” because they failed to “conform to compendial standards for strength, quality, or purity.”
Based on the FDA’s Warning Letter, it appears the agency is not convinced the recall captured all of the superpotent products Acella manufactured. Accordingly, the FDA is requiring Acella to run additional tests and assessments on its products to determine the strength of active ingredients in each product batch. Acella is further required to provide FDA with an action plan and comprehensive assessment and remediation plan.
If you or a loved one have been injured by a super potent dose of NP Thyroid ®, the Cincinnati dangerous drug attorneys at Burg Simpson can help. Burg Simpson has successfully represented thousands of individuals who suffered injuries due to defective drugs. We know what it takes to hold pharmaceutical companies responsible for their actions and secure just compensation for our clients. Call Burg Simpson’s product liability attorneys in Cincinnati, Ohio office today at 513-852-5600 or fill out our free case evaluation form now to discuss your case with us.