Why it was recalled
CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
Product description
Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with "H" on one side and "145" on the other side.
Lot numbers, UPCs & expiration codes
Pharma Pac NDC: 76519-1033-03, Pharma Pac Lot # LTO00EW, Exp. 11/19, MFG NDC 31722-0702-30, MFG Lot # LOP17087, Exp. 11/2019.
Where it was sold
Product was distributed to a physician's office in California.
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-1083-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 4, 2019
- FDA report date
- Apr 17, 2019
- Quantity
- 300 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- H J Harkins Company Inc dba Pharma Pac
Original FDA data
Every field from FDA enforcement report D-1083-2019, exactly as published.
Show all FDA fields
- City
- Grover Beach
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 82574
- Address
- 1400 W Grand Ave Ste F
- Code information
- Pharma Pac NDC: 76519-1033-03, Pharma Pac Lot # LTO00EW, Exp. 11/19, MFG NDC 31722-0702-30, MFG Lot # LOP17087, Exp. 11/2019.
- Postal code
- 93433-4221
- Report date
- Apr 17, 2019
- Product type
- Drugs
- Recall number
- D-1083-2019
- Classification
- Class II
- Recalling firm
- H J Harkins Company Inc dba Pharma Pac
- Product quantity
- 300 tablets
- Termination date
- May 24, 2023
- Reason for recall
- CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with "H" on one side and "145" on the other side.
- Distribution pattern
- Product was distributed to a physician's office in California.
- Recall initiation date
- Mar 4, 2019
- Initial firm notification
- Letter
- Center classification date
- Apr 7, 2019