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Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, In...

FDA Recall #D-0087-2023 — Class II — December 16, 2022

Recall #D-0087-2023 Date: December 16, 2022 Classification: Class II Status: Ongoing

Product Description

Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01

Reason for Recall

Failed Impurities/Degradation Specifications

Recalling Firm

Aurolife Pharma, LLC — Dayton, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

7344 bottles

Distribution

Nationwide in the USA and Puerto Rico.

Code Information

Lots: 01422002A1, Expiry: 12/2023; 01421078A3, Expiry: 09/2023

Status

Ongoing

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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