Why it was recalled
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Product description
Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Lot numbers, UPCs & expiration codes
Lot # BLI2107B, exp. date 06/2023 BLI2101A, exp. date 12/2022 BLI2103A, exp. date 12/2022 BLI2105A, exp. date 05/2023
Where it was sold
Product was distributed nationwide.
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-0834-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 15, 2022
- FDA report date
- May 11, 2022
- Quantity
- 3288/30 count bottles; 23,904/90 count bottles; 3364/1000 count bottles = 5,614,000 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Macleods Pharma Usa Inc
Original FDA data
Every field from FDA enforcement report D-0834-2022, exactly as published.
Show all FDA fields
- City
- Plainsboro
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90037
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230
- Code information
- Lot # BLI2107B, exp. date 06/2023 BLI2101A, exp. date 12/2022 BLI2103A, exp. date 12/2022 BLI2105A, exp. date 05/2023
- Postal code
- 08536-0009
- Report date
- May 11, 2022
- Product type
- Drugs
- Recall number
- D-0834-2022
- Classification
- Class II
- Recalling firm
- Macleods Pharma Usa Inc
- Product quantity
- 3288/30 count bottles; 23,904/90 count bottles; 3364/1000 count bottles = 5,614,000 tablets
- Termination date
- Oct 13, 2023
- Reason for recall
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
- Distribution pattern
- Product was distributed nationwide.
- Recall initiation date
- Apr 15, 2022
- Initial firm notification
- Letter
- Center classification date
- May 3, 2022