Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
National Drug Code
Is NDC 69097-0412-02 recalled?
Cinacalcet · 30 TABLET in 1 BOTTLE (69097-412-02)
Yes — this exact package was recalled
3 FDA recalls name the code 69097-0412-02 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.
3 of these recalls are still ongoing.
- Active ingredient
- Cinacalcet
- Strength
- CINACALCET HYDROCHLORIDE 90 mg/1
- Form
- Tablet · Oral
- Labeler
- Cipla USA Inc.
- Type
- Human Prescription Drug
- Product code
- 69097-0412
Recalls naming this package
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
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
- 69097-0341 Difluprednate 3
- 69097-0410 Cinacalcet 3
- 69097-0411 Cinacalcet 3
- 69097-0142 Albuterol Sulfate 2
- 69097-0537 Testosterone Cypionate 2
- 69097-0870 Lanreotide Acetate 2
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