FDAClass IIMarch 27, 2019

Glycopyrrolate 0.6 mg/3 mL recall: Sterility Concern

Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile single use syringe, For IV or IM use, NDC: 42852-828-22 Avella of Houston…

Why was Glycopyrrolate 0.6 mg/3 mL recalled?

Lack of Assurance of Sterility

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?

Lots: 10/31/18 2288 82822S Exp. 3/30/2019; 10/18/18 8371 82822S Exp. 3/17/2019

Product
Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile single use syringe, For IV or IM use, NDC: 42852-828-22 Avella of Houston…
Recalling firm
Advanced Pharma Inc.
Quantity
140 syringes
Distribution
Nationwide
Recall date
March 27, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls