Drug 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.
D-0940-2023
Product summary
- Event
- Event 92680
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7313 bottles
- Official record key
drug-enforcement:D-0940-2023
Official wording
Reason: Presence of Foreign Substance: Metal embedded in a tablet.
Code information: Lot AC74459, Exp 07/31/2024
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance