A large number of injections have been recalled!

On August 18, the FDA's website announced that a U.S. drug company had voluntarily recalled sodium heparin intravenous bag products nationwide because of improper use of preservatives.
FDA Release Date: August 18, 2020 Product Category: Drug Announcement Reason: Incorrect Preservatives (Benzool) Recall Company: SCA Pharmaceuticals Product Description: Heparin Sodium Intravenous Bag Recall Cause SCA Pharmaceuticals, Windsor City, USA, voluntarily recalled 10 batches of sodium heparin.
recalled to hospital/user levels because heparin sodium products contain the unstated preservative benzoyl alcohol.
preservatives are parabens and parabens listed on their labels.
, the preservatives present in the product do not match the label.
SCA Pharmaceuticals discovered the label problem during an investigation into low product content bias.
sodium heparin as an anticoagulant and is packaged in 500 mL or 1000 mL intravenous bags.
this affected heparin sodium batch includes: Adverse reactions to benzoyl alcohol Benzo alcohol is prohibited for use in children as well as pregnant or lactating women.
The use of benzoyl alcohol as a preservative at the time, regardless of its content, can lead to fatal reactions and severe adverse reactions, including "breathing syndrome", in premature and low-birth-weight infants in neonatal intensive care units.
other adverse reactions include gradual deterioration of the nervous system, seizures, skull bleeding, blood abnormalities, ruptured skin, liver and kidney failure, low blood pressure, slower-than-expected heart rhythms, and loss of adequate cerebral blood flow to maintain awareness.
babies born prematurely and low birth weight may be more likely to have these reactions because they have lower metabolism.
addition, phenyl methanol present in the mother's serum may penetrate into breast milk and may be absorbed oral by nursing infants.
, when heparin treatment is required during pregnancy, it is recommended to inject sodium heparin without preservatives.
SCA Pharmaceuticals said it had not received any complaints or adverse event reports related to the recall so far.
, however, SCA Pharmaceuticals voluntarily recalls the batches listed here out of caution.
announcement that the heparin sodium product is distributed to hospitals nationwide in the United States in the form of hospital distribution.
can identify sodium heparin by checking the product name, concentration and lot number on the bag.
SCA Pharmaceuticals is notifying its customers and is arranging a refund of all recalled products.
hospital should stop using the product and return it to SCA.
adverse reactions or quality issues encountered in using this product can be reported to the FDA's MedWatch Adverse Event Reporting Program online, by regular mail or fax.
recall was made with the FDA's knowledge.
SCA Pharmaceuticals, an outsourcing facility for the deployment of drugs, is itself positioned as an "industry-leading 503B organization" for the deployment of drugs (compounded drugs) to address the clinical needs of certain individual patients listed earlier.
For the clinical needs of these individual patients, the FDA allows the provision of drugs, which is Section 503A (Pharmacy Preparations) and 503B (Outsourcing Site Preparations) of the Federal Food, Drug, and Cosmetic Act.
In the U.S., hospital pharmacies and social pharmacies that provision drugs, or entrust outsourced sites to provision drugs, do not require approval, that is, exemption from approval, but the FDA retains the right to regulate sites for deployment, send warning letters and take regulatory action against sites that do not meet the requirements.
the end of 2012, the United States suffered the worst drug-poisoning incident in recent history, in which hundreds of people in 20 states contracted fungal infections caused by the use of the drug, resulting in more than 60 deaths.
Ref.: (FDA) sCA Pharmaceuticals (SCA) Is Issuing a Voluntary Nationalwide Recall of Heparin Sodium Compounded Products Due to Martin Preservative (Benzyl Alcohol)