D-0391-2026 Class III Ongoing
FDA drug recall D-0391-2026 was initiated by Annora Pharma Private Limited on February 3, 2026 and is designated Class III. Reason for recall: Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg The recall status is ongoing. Affected quantity: 770 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 25, 2026
- Initiation Date
- February 3, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 770 bottles
Product Description
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.
Reason for Recall
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Distribution Pattern
TN
Code Information
Lot #: A252487, Exp 05/31/2027