FDAClass IIMay 31, 2023

Modified del Nido Microplegia recall: Sterility Concern

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.

Why was Modified del Nido Microplegia recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 37-893821, Exp 04/28/2023; 37-894813, 37-894815, Exp 04/30/2023; 37-895489, 37-895490, Exp 05/05/2023; 37-897810, 37-897811, Exp 05/13/2023; 37-899585, Exp 05/20/2023

Product
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.
Recalling firm
Central Admixture Pharmacy Services, Inc.
Quantity
690 syringes
Distribution
Nationwide in the USA.
Recall date
May 31, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls