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On March 11, the FDA issued a recall announcement, and the US Saijin Pharmaceuticals voluntarily recalled three batches of injection products.
The recall originated from a customer complaint that indicated the possibility of loosening of the cap seal of the vial, which indicated that the aseptic performance of the product could not be guaranteed.
Company announcement date: March 11, 2021
FDA release date: March 11, 2021
Product Category: Medicine
Recall reason: lack of sterility guarantee
Recall company: Saijin Pharmaceutical
Product description: Phenylephrine Hydrochloride Injection
Company Announcement
Company AnnouncementSagent Pharmaceuticals, Inc.
Figure: The importance of the cap seal of the vial for sterile preparations-from left to right are incomplete capping, correct capping, and over capping
Security Risk
Security RiskPhenylephrine hydrochloride injection is an alpha-1 adrenergic receptor agonist used to treat clinically significant hypotension, which can be caused by vasodilation under anesthesia.
Picture: The label of the recalled product
If the sterile preparations for intravenous injection are in a non-sterile state, they may cause serious systemic infections, which can be life-threatening.
Recall arrangement
Recall arrangementThe product is provided in the form of a 3 mL glass tube vial.
Picture: Information of the recalled product (product, batch number, expiration date, NDC number, distribution date)
Saijin Pharmaceuticals is notifying customers via fax, e-mail, FedEx and/or certified mail, including arrangements for returning all recalled products.
If customers or consumers have any questions about returning unused products, they can call the customer service center of Saijin Pharmaceutical; medical personnel who have medical questions about this product can contact the Medical Affairs Department of Saijin Pharmaceutical.
For adverse reactions or quality problems encountered using this product, you can report to the FDA's MedWatch Adverse Event Program online, regular mail or fax.
The recall was carried out with the knowledge of the US FDA.
