Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.
News|Articles|March 15, 2021
Sagent Pharmaceuticals Issues Voluntary Nationwide Recall for its Low Blood Pressure Treatment
Author(s)Pharmaceutical Technology Editors
Sagent Pharmaceuticals is voluntarily recalling three lots of Phenylephrine Hydrochloride Injection, USP (10 mg/mL) to the user level because of a customer complaint regarding potentially loose crimped vial overseals, which can result in a non-sterile product.
Advertisement
Sagent Pharmaceuticals announced on March 11, 2021 that it is voluntarily recalling three lots of Phenylephrine Hydrochloride Injection, USP (10 mg/mL), an alpha-1 adrenergic receptor agonist for the treatment of low blood pressure resulting from the dilation of blood vessels, to the user level because of a customer complaint regarding potentially loose crimped vial overseals, which can result in a non-sterile product.
Administering a product intended to be sterile but that is not sterile could result in systemic infections which may be life-threatening, FDA said in a press release. Sagent is recalling lot numbers PHT8IB2, PHT9IB2, and PHT1JB2 distributed nationwide in the US from Nov. 17, 2020 to March 8, 2021. Currently, the company has not received any reports of adverse events associated with the product.
Source:
Advertisement
Related to this article
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.
Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.
Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.
Michael Levy, senior vice president, Digital & Innovation, USP, explains the digital supply chain in a preview of his upcoming CPHI Milan panel presentation, The Next Phase of Pharma Supply Chains.
FDA approves tavapadon, first D1/D5 agonist, validating AbbVie's $8.7B Cerevel deal and an October five-strength oral tablet launch.
Merck licenses SciBrunch's preclinical KRAS G12D inhibitor for $2.13B, raising tech transfer and scale-up questions for oral cancer drug development.
Ronald Piervincenzi, USP, urges drugmakers and purchasers to act on supply chain resilience to curb drug shortages and shape better policy.
Advertisement
Advertisement