FDAClass IIDecember 21, 2016

Glycopyrrolate 1 mg/5 mL recall: Sterility Concern

Glycopyrrolate 1 mg/5 mL (0.2 mg/mL) Injection Solution, 5 mL Single-Dose Syringe, For IV Use, Hospital/Office Use Only, Rx Only, Cantrell Drug Co.…

Why was Glycopyrrolate 1 mg/5 mL recalled?

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

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: 9006 BUD: 1/20/2017, Lot: 8757 BUD: 11/30/2016, Lot: 8954 BUD: 1/6/2017, Lot: 9174 BUD: 2/20/2017

Product
Glycopyrrolate 1 mg/5 mL (0.2 mg/mL) Injection Solution, 5 mL Single-Dose Syringe, For IV Use, Hospital/Office Use Only, Rx Only, Cantrell Drug Co.…
Recalling firm
Cantrell Drug Company
Quantity
48,592 syringes
Distribution
Nationwide
Recall date
December 21, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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