Drug Enforcement D-0570-2023

Product mixup: one foreign tablet found in product.

Status

Terminated

Classification

Class III

Report Date

May 17, 2023

Termination Date

April 30, 2024

Product Information

Product description
Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. East Windsor, NJ 08520 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA, NDC 0904-6823-61
Product quantity
3984 cartons
Reason for recall
Product mixup: one foreign tablet found in product.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
The Harvard Drug Group
Address
341 Mason Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0570-2023
Event ID
92174
Recall initiation date
April 24, 2023
Center classification date
May 10, 2023
Code info
Lot: T04468, Exp 10/2024
More code info
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