Why it was recalled
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Product description
Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc.
Lot numbers, UPCs & expiration codes
Lot: E1321O, Exp.: 5/31/2023 Lot: E2521H, Exp.: 5/31/2023 Lot: E2621F, Exp.: 5/31/2023
Where it was sold
Nationwide within the U.S to CA, IN and FL.
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-0789-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 12, 2022
- FDA report date
- May 4, 2022
- Quantity
- 44 Bottles of 90 Tablets 33 Bottles of 30 Tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Preferred Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0789-2022, exactly as published.
Show all FDA fields
- City
- Anaheim
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 90001
- Address
- 1250 N Lakeview Ave Ste O
- Code information
- Lot: E1321O, Exp.: 5/31/2023 Lot: E2521H, Exp.: 5/31/2023 Lot: E2621F, Exp.: 5/31/2023
- Postal code
- 92807-1801
- Report date
- May 4, 2022
- Product type
- Drugs
- Recall number
- D-0789-2022
- Classification
- Class II
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Product quantity
- 44 Bottles of 90 Tablets 33 Bottles of 30 Tablets
- Termination date
- Sep 22, 2022
- Reason for recall
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc.
- Distribution pattern
- Nationwide within the U.S to CA, IN and FL.
- Recall initiation date
- Apr 12, 2022
- Initial firm notification
- Letter
- Center classification date
- Apr 26, 2022