PlainRecalls
FDA Drug Moderate Class II Terminated

Modified del Nido Microplegia, packaged in 40 mL per syringe, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0219-1.

Reported: May 31, 2023 Initiated: April 28, 2023 #D-0681-2023

Product Description

Modified del Nido Microplegia, packaged in 40 mL per syringe, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0219-1.

Reason for Recall

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Details

Units Affected
690 syringes
Distribution
Nationwide in the USA.
Location
Allentown, PA

Frequently Asked Questions

What product was recalled?
Modified del Nido Microplegia, packaged in 40 mL per syringe, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0219-1.. Recalled by Central Admixture Pharmacy Services, Inc.. Units affected: 690 syringes.
Why was this product recalled?
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 31, 2023. Severity: Moderate. Recall number: D-0681-2023.