FDA-Drug2026-03-25Class III

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.

Annora Pharma Private Limited
Hazard
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Sold states
TN
Affected count
770 bottles
Manufactured in
Sy. No.261, Plot No. 13 And 14, Annaram Village, Gummadidal Mandal, Jinnaram Mandal, Sangareddy District, Medak, Hyderabad, N/A, India
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0391-2026

Original summary

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. Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg Lot #: A252487, Exp 05/31/2027 Distribution: TN Affected quantity: 770 bottles

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