Drug product
Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-143-01
D-0574-2025
Product summary
- Event
- Event 97391
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11,328 bottles
- Official record key
drug-enforcement:D-0574-2025
Official wording
Reason: Presence of foreign substance: identified as aluminum.
Code information: Lot # P3314, Exp 11/30/2026
Distribution pattern: USA Nationwide
Derived failure modes
-
Foreign material or chemical contamination
foreign substance