Drug product
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.
D-0762-2022
Product summary
- Event
- Event 89766
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4872 bottles
- Official record key
drug-enforcement:D-0762-2022
Official wording
Reason: FAILED CONTENT UNIFORMITY SPECIFICATIONS
Code information: Lot #: BRD2001A, Exp 5/2022
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
FAILED CONTENT UNIFORMITY SPECIFICATIONS