Class II · Moderate risk
Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
National Drug Code
Is NDC 33342-0052-44 recalled?
Losartan potassium and Hydrochlorothiazide · 1000 TABLET, FILM COATED in 1 BOTTLE (33342-052-44)
Yes — this exact package was recalled
2 FDA recalls name the code 33342-0052-44 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- Losartan potassium and Hydrochlorothiazide
- Strength
- LOSARTAN POTASSIUM 100 mg/1; HYDROCHLOROTHIAZIDE 25 mg/1
- Form
- Tablet, Film Coated · Oral
- Labeler
- Macleods Pharmaceuticals Limited
- Type
- Human Prescription Drug
- Product code
- 33342-0052
Recalls naming this package
Class II · Moderate risk
Losartan Potassium & Hydrochlorothiazide Tablets
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 33342-0050 Losartan potassium and Hydrochlorothiazide 4
- 33342-0045 Losartan potassium 3
- 33342-0031 Pramipexole dihydrochloride 2
- 33342-0051 Losartan potassium and Hydrochlorothiazide 2
- 33342-0192 AMLODIPINE and OLMESARTAN medoxomil 2
- 33342-0022 See recall 1
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