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Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 25 mg/1000 mg 30...

FDA Recall #D-0458-2021 — Class II — March 15, 2021

Recall #D-0458-2021 Date: March 15, 2021 Classification: Class II Status: Terminated

Product Description

Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 25 mg/1000 mg 30 tablets Rx only NDC 0597-0295-88 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Recalling Firm

Cardinal Health Inc. — Dublin, OH

Classification

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

Product Type

Drugs

Product Quantity

269 bottles

Distribution

FL, GA, SC

Code Information

3191432

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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