Recalls / Class II
Class IID-1101-2020
Product
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
- Affected lot / code info
- Lots 1195625A, 1195624A, 1195623A, exp. date 03/2020
Why it was recalled
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- N/A
- Distribution pattern
- Bulk product was distributed to one re-packager in California.
Timeline
- Recall initiated
- 2020-03-25
- FDA classified
- 2020-04-07
- Posted by FDA
- 2020-04-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1101-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.