Drug Enforcement D-0940-2023

Presence of Foreign Substance: Metal embedded in a tablet.

Status

Terminated

Classification

Class II

Report Date

August 2, 2023

Termination Date

February 12, 2024

Product Information

Product description
Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 57664-230-88.
Product quantity
7313 bottles
Reason for recall
Presence of Foreign Substance: Metal embedded in a tablet.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

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-0940-2023
Event ID
92680
Recall initiation date
July 13, 2023
Center classification date
July 24, 2023
Code info
Lot AC74459, Exp 07/31/2024
More code info
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