Moderate riskFDA DrugClass III
Annora Pharma Pitavastatin 2mg tablets recalled for wrong-strength tablet contamination
A 1 mg Pitavastatin tablet was found mixed into a bottle labeled as containing 2 mg tablets. This occurred in one lot (A252487) distributed in Tennessee. Taking the wrong dose by mistake could affect how well your cholesterol medication works.
From the FDA notice · Read the official notice ↗
What to do
- Check if you have Pitavastatin 2 mg, lot A252487, expiration 05/31/2027 (NDC 72603-479-01)
- Do not take tablets from the affected bottle
- Call your pharmacist or doctor before stopping your medication
- Return the bottle to your pharmacy
Is yours affected?
Compare your label or packaging with the recalled product.
- 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.
- Sold in
- TN
- Made for
- Adults (under 0 months)
Details
- Units affected
- 770 bottles
- Illnesses reported
- None reported
- Manufactured in
- Sy. No.261, Plot No. 13 And 14, Annaram Village, Gummadidal Mandal, Jinnaram Mandal, Sangareddy District, Medak, Hyderabad, N/A, India
- Classification
- Class III
- Recall number
- D-0391-2026
In the FDA's words
- 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. 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
- Hazard
- Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg