Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Product type
Drug
Status
Terminated
Report date
2023-08-02
Distribution
Nationwide
Firm state
NJ
Product quantity
7313 bottles
Initiated by
Voluntary: Firm initiated
Reason for recall
Presence of Foreign Substance: Metal embedded in a tablet.
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.
Code / lot info
Lot AC74459, Exp 07/31/2024
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.