Why it was recalled
Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product complaint where one of Lupin's Fenofibrate 145mg was observed in the 500 s count product bottle.
Product description
Lisinopril/HCTZ 20mg/12.5mg Tablet, QTY: 30 tablets per blister card, MFG: Lupin Pharma Baltimore, MD 21202, NDC 68180-0519-02 (Original NDC of 500 count bottle); 70518-0382-03 (Repackaged NDC for blister cards).
Lot numbers, UPCs & expiration codes
Lot #: J0322819-091418, Exp: 09/30/2019
Where it was sold
PA
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-1030-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 5, 2019
- FDA report date
- Mar 25, 2020
- Quantity
- 480 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-1030-2020, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 83645
- Address
- 625 Kolter Dr Ste 4
- Code information
- Lot #: J0322819-091418, Exp: 09/30/2019
- Postal code
- 15701-3571
- Report date
- Mar 25, 2020
- Product type
- Drugs
- Recall number
- D-1030-2020
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- 480 tablets
- Termination date
- Jun 2, 2023
- Reason for recall
- Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product complaint where one of Lupin's Fenofibrate 145mg was observed in the 500 s count product bottle.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lisinopril/HCTZ 20mg/12.5mg Tablet, QTY: 30 tablets per blister card, MFG: Lupin Pharma Baltimore, MD 21202, NDC 68180-0519-02 (Original NDC of 500 count bottle); 70518-0382-03 (Repackaged NDC for blister cards).
- Distribution pattern
- PA
- Recall initiation date
- Aug 5, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 16, 2020