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 90 film coated tablets 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 23155-646-09
Lot numbers, UPCs & expiration codes
Lot CLO17012A exp 11/2019 Lot CLO17013A exp 11/2019 Lot CLO18002A exp 01/2020 Lot CLO18020A exp 04/2020 Lot CLO18021A exp 04/2020 Lot CLO18022A exp 04/2020
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-1288-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 3, 2019
- FDA report date
- May 29, 2019
- Quantity
- 25220 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Heritage Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1288-2019, 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
- Lot CLO17012A exp 11/2019 Lot CLO17013A exp 11/2019 Lot CLO18002A exp 01/2020 Lot CLO18020A exp 04/2020 Lot CLO18021A exp 04/2020 Lot CLO18022A exp 04/2020
- Postal code
- 08816-1145
- Report date
- May 29, 2019
- Product type
- Drugs
- Recall number
- D-1288-2019
- Classification
- Class II
- Recalling firm
- Heritage Pharmaceuticals, Inc.
- Product quantity
- 25220 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 90 film coated tablets 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 23155-646-09
- Distribution pattern
- Nationwide
- Recall initiation date
- May 3, 2019
- Initial firm notification
- Press Release
- Center classification date
- May 21, 2019