RISEDRONATE SODIUM Recall D-0762-2022
Description: Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., BAddi, HImchal Pradesh, INDIA, NDC 33342-107-07.
RISEDRONATE SODIUM Recall D-0762-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0762-2022 |
| Event ID | 89766 |
| Brand | RISEDRONATE SODIUM |
| Generic Name | RISEDRONATE SODIUM |
| Manufacturer | RISEDRONATE SODIUM |
| Original Package? | 1 |
| Active Substance | RISEDRONATE SODIUM |
| Drug Route | ORAL |
| Distribution | USA Nationwide |
| Quantity | 4872 bottles |
| Recall Reason | FAILED CONTENT UNIFORMITY SPECIFICATIONS |
| Drug Classification | Class III |
| Drug Code Info | 20220413 |
| Product NDC | 33342-107 33342-108 33342-109 |
| Recall Initiation Date | 20220310 |
| Report Date | 20220413 |
| Classification Date | 20220407 |
| Address | 666 Plainsboro Rd Bldg 200 Ste 230 Plainsboro, NJ 08536-0009 United States |
| Recalling Firm | Macleods Pharma Usa Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | OFG5EXG60L |
| Drug Application Number | ANDA203533 |
| Structured Product Labeling (SPL ID) | 4607af24-13bd-474e-8488-1a73488af3e2 |
| Structured Product Labeling (SPL Set ID) | 62aff8d6-a2f7-4c7e-a102-c70105ac3792 |
| Similar To |