Why it was recalled
Failed Impurities/Degradation Specifications.
Product description
Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3631-98.
Lot numbers, UPCs & expiration codes
P051001, P051002, & P051003, Exp Date 07/2025; P051005, Exp Date 10/2025; P051006, Exp Date 10/2025; P051007, Exp Date 01/2026; P051010, Exp Date 07/2026; P051011 & P051012, Exp Date 09/2026; P051013, P051014 and P051015, Exp Date 01/2027.
Where it was sold
NJ
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0527-2025
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Jun 11, 2025
- FDA report date
- Jul 9, 2025
- Quantity
- 20618 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Orient Pharma Co., Ltd. Yunlin Plant
Original FDA data
Every field from FDA enforcement report D-0527-2025, exactly as published.
Show all FDA fields
- City
- Yunlin County
- Status
- Ongoing
- Country
- Taiwan
- Event ID
- 97076
- Address
- No. 8 Kehu 1st Rd.
- Address (line 2)
- Huwei Township
- Code information
- P051001, P051002, & P051003, Exp Date 07/2025; P051005, Exp Date 10/2025; P051006, Exp Date 10/2025; P051007, Exp Date 01/2026; P051010, Exp Date 07/2026; P051011 & P051012, Exp Date 09/2026; P051013, P051014 and P051015, Exp Date 01/2027.
- Report date
- Jul 9, 2025
- Product type
- Drugs
- Recall number
- D-0527-2025
- Classification
- Class III
- Recalling firm
- Orient Pharma Co., Ltd. Yunlin Plant
- Product quantity
- 20618 bottles
- Reason for recall
- Failed Impurities/Degradation Specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3631-98.
- Distribution pattern
- NJ
- Recall initiation date
- Jun 11, 2025
- Initial firm notification
- Letter
- Center classification date
- Jul 16, 2025