Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
National Drug Code
Is NDC 0069-0468-56 recalled?
Chantix · 56 TABLET, FILM COATED in 1 BOTTLE (0069-0468-56)
Yes — this exact package was recalled
3 FDA recalls name the code 0069-0468-56 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.
2 of these recalls are still ongoing.
- Active ingredient
- varenicline tartrate
- Strength
- VARENICLINE TARTRATE .5 mg/1
- Form
- Tablet, Film Coated · Oral
- Labeler
- Pfizer Laboratories Div Pfizer Inc
- Type
- Human Prescription Drug
- Product code
- 0069-0468
Recalls naming this package
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Varenicline
Labeling: Label Mixup: VARENICLINE, Tablet, 0.5 mg may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS GG, Capsule, 0, NDC 49100036374, Pedigree: W003051, EXP: 6/12/2014; SOTALOL HCL, Tablet, 160 mg, NDC 00093106201, Pedigree: AD22609_10, EXP: 4/30/2014; VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: AD62796_4, EXP: 5/22/2014.
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
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