Drug Enforcement D-0914-2023

Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing

Status

Terminated

Classification

Class II

Report Date

July 19, 2023

Termination Date

December 18, 2023

Product Information

Product description
Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India. NDC#: 62756-200-83
Product quantity
8,880 30-count bottles
Reason for recall
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Distributed nationwide in the USA.

Location & Firm

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Address
2 Independence Way, N/A

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

Codes & Dates

Recall number
D-0914-2023
Event ID
92671
Recall initiation date
July 10, 2023
Center classification date
July 11, 2023
Code info
Lot HAC3339A, Expires 07/2023
More code info
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