FDAClass IIMarch 8, 2023

Glycopyrrolate Injection recall: CGMP Deviations

Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial, 10vial carton, Rx Only, Manufactured for: Accord Healthcare, Inc.…

Why was Glycopyrrolate Injection recalled?

CGMP Deviations: recalling drug products following an FDA inspection.

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?

Batches: R2200431, Exp. Date 7/31/2023, R2200439, Exp. Date 9/30/2023

Product
Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial, 10vial carton, Rx Only, Manufactured for: Accord Healthcare, Inc.…
Recalling firm
Accord Healthcare, Inc.
Quantity
322 vials
Distribution
United States including Puerto Rico and Canada
Recall date
March 8, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls