Why it was recalled
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Product description
Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-646-10
Lot numbers, UPCs & expiration codes
CLO17014A exp 12/2019 CLO17015A exp 01/2020 CLO17016A exp 01/2020 CLO17017A exp 01/2020 CLO18001A exp 01/2020 CLO18002B exp 01/2020
Where it was sold
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-1290-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 3, 2019
- FDA report date
- May 29, 2019
- Quantity
- 3697 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Heritage Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1290-2019, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82782
- Address
- 1 Tower Center Blvd Ste 1700
- Code information
- CLO17014A exp 12/2019 CLO17015A exp 01/2020 CLO17016A exp 01/2020 CLO17017A exp 01/2020 CLO18001A exp 01/2020 CLO18002B exp 01/2020
- Postal code
- 08816-1145
- Report date
- May 29, 2019
- Product type
- Drugs
- Recall number
- D-1290-2019
- Classification
- Class II
- Recalling firm
- Heritage Pharmaceuticals, Inc.
- Product quantity
- 3697 bottles
- Termination date
- Nov 16, 2020
- Reason for recall
- CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-646-10
- Distribution pattern
- Nationwide
- Recall initiation date
- May 3, 2019
- Initial firm notification
- Press Release
- Center classification date
- May 21, 2019