Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141
Summary
The FDA issued a Class III for Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured by Annora Pharma Private Limited. Reason: Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg.
Details
Source
Drug Recall
External ID
D-0391-2026
Action Date
2026-03-25
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot #: A252487, Exp 05/31/2027
Quantity Affected: 770 bottles
Reason for Recall
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Distribution
TN
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-03
Company
Hyderabad, N/A
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 46 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Annora Pharma Private Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Annora Pharma Private Limited have FDA actions?
This is the only FDA action we have on record for Annora Pharma Private Limited in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0391-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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