D-0940-2023 Class II Terminated
FDA drug recall D-0940-2023 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on July 13, 2023 and is designated Class II. Reason for recall: Presence of Foreign Substance: Metal embedded in a tablet. The recall status is terminated (terminated February 12, 2024). Affected quantity: 7313 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 2, 2023
- Initiation Date
- July 13, 2023
- Termination Date
- February 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7313 bottles
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.
Reason for Recall
Presence of Foreign Substance: Metal embedded in a tablet.
Distribution Pattern
Nationwide
Code Information
Lot AC74459, Exp 07/31/2024