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Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limi...

FDA Recall #D-0634-2024 — Class II — July 31, 2024

Recall #D-0634-2024 Date: July 31, 2024 Classification: Class II Status: Terminated

Product Description

Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA NDC 70010-227-05

Reason for Recall

Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets

Recalling Firm

Granules Pharmaceuticals Inc. — Chantilly, VA

Classification

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

Product Type

Drugs

Product Quantity

11,808 500-count Bottles

Distribution

Nationwide in the USA

Code Information

Lot 1380040A, Exp. date July 31, 2025

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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