FDA recall D-0940-2023

Product

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.

Reason for recall

Presence of Foreign Substance: Metal embedded in a tablet.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2023-07-13

Report date

2023-08-02

Termination date

2024-02-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0940-2023