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GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually...

FDA Recall #D-0020-2022 — Class II — September 17, 2021

Recall #D-0020-2022 Date: September 17, 2021 Classification: Class II Status: Terminated

Product Description

GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx only, Manufactured by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054. Carton NDC#: 68084-295-21 (Individual Dose NDC: 68084-295-11)

Reason for Recall

Failed Dissolution Specifications: results were above specification.

Recalling Firm

American Health Packaging — Columbus, OH

Classification

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

Product Type

Drugs

Product Quantity

2,266 cartons

Distribution

Nationwide within the USA

Code Information

Lot #: 194141, Exp. Date 03/31/2022

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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