Recalls / Class III
Class IIID-0391-2026
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.
- Brand name
- Pitavastatin Calcium
- Generic name
- Pitavastatin Calcium
- Active ingredient
- Pitavastatin Calcium
- Route
- Oral
- NDCs
- 72603-479, 72603-480
- FDA application
- ANDA205977
- Affected lot / code info
- Lot #: A252487, Exp 05/31/2027
Why it was recalled
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Recalling firm
- Firm
- Annora Pharma Private Limited
- Manufacturer
- NorthStar RxLLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Sy. No.261, Plot No. 13 And 14, Annaram Village, Gummadidal Mandal, Jinnaram Mandal, Sangareddy District, Medak, Hyderabad, N/A N/A, India
Distribution
- Quantity
- 770 bottles
- Distribution pattern
- TN
Timeline
- Recall initiated
- 2026-02-03
- FDA classified
- 2026-03-16
- Posted by FDA
- 2026-03-25
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0391-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.