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 Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA, Mfg: Torrent Pharma Inc., Basking Ridge, NJ
Lot numbers, UPCs & expiration codes
a) 30 tablets: lot A1818G batch 01181807 exp 3/2020; b) 90 tablets: lot L0517L batch 12051712 exp 3/2020
Where it was sold
CA, GA, IN. No DOD/VA accounts. No foreign accounts.
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-1281-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 30, 2019
- FDA report date
- May 22, 2019
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Preferred Pharmaceuticals, Inc
Original FDA data
Every field from FDA enforcement report D-1281-2019, exactly as published.
Show all FDA fields
- City
- Anaheim
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 82791
- Address
- 1250 N Lakeview Ave Ste O
- Code information
- a) 30 tablets: lot A1818G batch 01181807 exp 3/2020; b) 90 tablets: lot L0517L batch 12051712 exp 3/2020
- Postal code
- 92807-1801
- Report date
- May 22, 2019
- Product type
- Drugs
- Recall number
- D-1281-2019
- Classification
- Class II
- Recalling firm
- Preferred Pharmaceuticals, Inc
- Termination date
- Apr 3, 2023
- 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 Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA, Mfg: Torrent Pharma Inc., Basking Ridge, NJ
- Distribution pattern
- CA, GA, IN. No DOD/VA accounts. No foreign accounts.
- Recall initiation date
- Apr 30, 2019
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- May 16, 2019