METHYLPHENIDATE HYDROCHLORIDE Recall D-0940-2023
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.
METHYLPHENIDATE HYDROCHLORIDE Recall D-0940-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0940-2023 |
| Event ID | 92680 |
| Brand | METHYLPHENIDATE HYDROCHLORIDE |
| Generic Name | METHYLPHENIDATE HYDROCHLORIDE |
| Manufacturer | METHYLPHENIDATE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | METHYLPHENIDATE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide |
| Quantity | 7313 bottles |
| Recall Reason | Presence of Foreign Substance: Metal embedded in a tablet. |
| Drug Classification | Class II |
| Drug Code Info | 20230802 |
| Product NDC | 57664-228 57664-229 57664-230 |
| Recall Initiation Date | 20230713 |
| Report Date | 20230802 |
| Classification Date | 20230724 |
| Address | 2 Independence Way Princeton, NJ 08540-6620 United States |
| Recalling Firm | SUN PHARMACEUTICAL INDUSTRIES INC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 4B3SC438HI |
| Drug Application Number | ANDA090710 |
| Structured Product Labeling (SPL ID) | 84879fd2-4f57-43ce-aebc-18690ce90fda |
| Structured Product Labeling (SPL Set ID) | 1a89b390-0cd5-45cb-9e70-20de44652c56 |
| Similar To |