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Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufa...

FDA Recall #D-0250-2021 — Class III — January 28, 2021

Recall #D-0250-2021 Date: January 28, 2021 Classification: Class III Status: Terminated

Product Description

Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India NDC 16729-472-08 (Vial NDC 16729-472-30)

Reason for Recall

Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials

Recalling Firm

Accord Healthcare, Inc. — Durham, NC

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

502 cartons

Distribution

Nationwide

Code Information

Lot: M2013645 Exp. Aug. 2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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