Drug product
Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd., Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-785-06.
D-1330-2022
Product summary
- Event
- Event 90634
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1032 bottles
- Official record key
drug-enforcement:D-1330-2022
Official wording
Reason: Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
Code information: Lot #: 7248988B, Exp 9/2023
Distribution pattern: US Nationwide
Derived failure modes
-
Foreign material or chemical contamination
foreign tablet