Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
Presence of foreign substance: plastic-like substance.
Losartan Potassium Tab. USP 50mg
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 at the manufacturer
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 Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA, Mfg: Torrent Pharma Inc., Basking Ridge, NJ
Affected NDCs
68788-0048-03
68788-0048-09
Compare with the code on your package — it is the most precise check available.
Drug: Losartan Category: Blood Pressure Medication
- Recalling firm
- Preferred Pharmaceuticals, Inc
- NDC code
- 68788-0048-03
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1281-2019 · 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 Preferred Pharmaceuticals, Inc
All 2019 recalls
Class II · Moderate risk
Artificial Tears Lubricant Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Ondansetron ODT Tablets
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class II · Moderate risk
Clindamycin Hydrochloride Capsules
cGMP Deviations
Class II · Moderate risk
Ibuprofen Tablets
Failed Impurities/Degradation Specifications - at 18-month Stability testing
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