Drug product
Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Pharma Pvt. LTd., Sengareddy - 502313, Telengana, India, NDC 72603-479-01.
D-0391-2026
Product summary
- Event
- Event 98543
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 770 bottles
- Official record key
drug-enforcement:D-0391-2026
Official wording
Reason: Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Code information: Lot #: A252487, Exp 05/31/2027
Distribution pattern: TN
Derived failure modes
-
Foreign material or chemical contamination
foreign tablets