D-1101-2020 Class II Ongoing
FDA drug recall D-1101-2020 was initiated by Teva Pharmaceuticals USA on March 25, 2020 and is designated Class II. Reason for recall: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- April 15, 2020
- Initiation Date
- March 25, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3746-00
Reason for Recall
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Distribution Pattern
Bulk product was distributed to one re-packager in California.
Code Information
Lots 1195625A, 1195624A, 1195623A, exp. date 03/2020