D-1083-2019 Class II Terminated
FDA drug recall D-1083-2019 was initiated by H J Harkins Company Inc dba Pharma Pac on March 4, 2019 and is designated Class II. Reason for recall: CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API). The recall status is terminated (terminated May 24, 2023). Affected quantity: 300 tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- April 17, 2019
- Initiation Date
- March 4, 2019
- Termination Date
- May 24, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 300 tablets
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.
Reason for Recall
CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
Distribution Pattern
Product was distributed to a physician's office in California.
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.