FDA DrugsClass III
Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured ...
Published: March 25, 2026Recall ID: D-0391-2026Category: drugsCountry: US
Reason for Recall / Hazard
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Hyderabad |
| State | N/A |
| Openfda › Unii | IYD54XEG3W |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 861648 |
| Openfda › Rxcui › 2 | 861652 |
| Openfda › Spl id | 27e1ba97-23bf-fc12-e063-6394a90a1699 |
| Openfda › Brand name | PITAVASTATIN CALCIUM |
| Openfda › Spl set id | 98e3f1df-5b38-4169-a340-adb145eac459 |
| Openfda › Package ndc › 1 | 72603-479-01 |
| Openfda › Package ndc › 2 | 72603-480-01 |
| Openfda › Product ndc › 1 | 72603-479 |
| Openfda › Product ndc › 2 | 72603-480 |
| Openfda › Generic name | PITAVASTATIN CALCIUM |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | PITAVASTATIN CALCIUM |
| Openfda › Manufacturer name | NorthStar RxLLC |
| Openfda › Application number | ANDA205977 |
| Openfda › Is original packager | true |
| Event id | 98543 |
| Address 1 | Sy. No.261, Plot No. 13 And 14, Annaram Village, Gummadidal Mandal |
| Address 2 | Jinnaram Mandal, Sangareddy District, Medak |
| Code info | Lot #: A252487, Exp 05/31/2027 |
| Postal code | N/A |
| Report date | 20260325 |
| Product type | Drugs |
| Product quantity | 770 bottles |
| Reason for recall | Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260203 |
| Initial firm notification | Letter |
| Center classification date | 20260316 |
Overview
- Recalling FirmAnnora Pharma Private Limited
- StatusOngoing
- Risk LevelClass III
- DistributionTN