Why it was recalled
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Product description
Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09
Lot numbers, UPCs & expiration codes
Lot # B1329507-082921, exp. date 08/31/2022 B1348363-091421, exp. date 09/30/2022 B1387286-101021, exp. date 10/31/2022 B1390974-101221, exp. date 10/31/2022 B1426010-110521, exp. date 11/30/2022
Where it was sold
Product was distributed to FL, SC and VA
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-0886-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 2, 2022
- FDA report date
- Jun 1, 2022
- Quantity
- 26/90 count bottles = 2,340 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-0886-2022, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 90127
- Address
- 625 Kolter Dr Ste 4
- Code information
- Lot # B1329507-082921, exp. date 08/31/2022 B1348363-091421, exp. date 09/30/2022 B1387286-101021, exp. date 10/31/2022 B1390974-101221, exp. date 10/31/2022 B1426010-110521, exp. date 11/30/2022
- Postal code
- 15701-3571
- Report date
- Jun 1, 2022
- Product type
- Drugs
- Recall number
- D-0886-2022
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- 26/90 count bottles = 2,340 tablets
- Termination date
- Sep 2, 2022
- Reason for recall
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09
- Distribution pattern
- Product was distributed to FL, SC and VA
- Recall initiation date
- May 2, 2022
- Initial firm notification
- Letter
- Center classification date
- May 20, 2022