D-0762-2022 Class III Terminated
FDA drug recall D-0762-2022 was initiated by Macleods Pharma Usa Inc on March 10, 2022 and is designated Class III. Reason for recall: FAILED CONTENT UNIFORMITY SPECIFICATIONS The recall status is terminated (terminated June 29, 2023). Affected quantity: 4872 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 13, 2022
- Initiation Date
- March 10, 2022
- Termination Date
- June 29, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4872 bottles
Product 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.
Reason for Recall
FAILED CONTENT UNIFORMITY SPECIFICATIONS
Distribution Pattern
USA Nationwide
Code Information
Lot #: BRD2001A, Exp 5/2022