Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
Presence of foreign substance: plastic-like substance.
Losartan Potassium Tablets USP 50 mg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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
Cause type: Nitrosamine impurity
Trace nitrosamine impurities such as NDMA, NDEA or NMBA found above the acceptable daily limit. Nitrosamines are probable human carcinogens that can form during manufacturing or storage. This is the cause behind the large valsartan, losartan and ranitidine (Zantac) recalls. All nitrosamine impurity recalls.
What was recalled
Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC 23155-645-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India, Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816 NDC 23155-645-09
Affected NDCs
23155-0645-03
23155-0645-09
23155-0645-10
Compare with the code on your package — it is the most precise check available.
Drug: Losartan Category: Blood Pressure Medication
- Recalling firm
- Avet Pharmaceuticals, Inc.
- NDC code
- 23155-645-03
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1103-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Losartan recalls
See all
Class II · Moderate risk
Losartan Potassium Tablets
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
Class II · Moderate risk
Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Other recalls by Avet Pharmaceuticals, Inc.
All 2020 recalls
Class II · Moderate risk
Losartan Potassium Tablets USP 100 mg
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level
Class I · High risk
Tetracycline HCL Capsules
Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Class I · High risk
Tetracycline HCL Capsules
Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
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