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
Product description
Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count (NDC 23155-646-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816
Lot numbers, UPCs & expiration codes
a) CL018022B, exp Apr 2020 b) CL018010A Mar 2020; CL018017B, CL018018A exp Apr 2020 c) CL018011A, CL018012A exp Mar 2020; CL018013A, CL018015A, CL018016A, CL018017A, exp Apr 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-1104-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 26, 2020
- FDA report date
- Apr 15, 2020
- Quantity
- a) 12,168; b) 17,196; c) 3,890
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Avet Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1104-2020, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 85283
- Address
- 1 Tower Center Blvd Ste 1700
- Code information
- a) CL018022B, exp Apr 2020 b) CL018010A Mar 2020; CL018017B, CL018018A exp Apr 2020 c) CL018011A, CL018012A exp Mar 2020; CL018013A, CL018015A, CL018016A, CL018017A, exp Apr 2020
- Postal code
- 08816-1145
- Report date
- Apr 15, 2020
- Product type
- Drugs
- Recall number
- D-1104-2020
- Classification
- Class II
- Recalling firm
- Avet Pharmaceuticals, Inc.
- Product quantity
- a) 12,168; b) 17,196; c) 3,890
- Termination date
- Mar 8, 2021
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count (NDC 23155-646-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 26, 2020
- Initial firm notification
- Letter
- Center classification date
- Apr 7, 2020