Class III · Low risk
Nicotine polacrilex lozenge
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
National Drug Code
Is NDC 0135-0510-01 recalled?
Nicorette · 3 CONTAINER in 1 CARTON (0135-0510-01) / 24 LOZENGE in 1 CONTAINER
Yes — this exact package was recalled
2 FDA recalls name the code 0135-0510-01 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
- nicotine polacrilex
- Strength
- NICOTINE 2 mg/1
- Form
- Lozenge · Oral
- Labeler
- Haleon US Holdings LLC
- Type
- Human OTC Drug
- Product code
- 0135-0510
Recalls naming this package
Class III · Low risk
Nicotine polacrilex lozenge
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class II · Moderate risk
Nicotine Polacrilex
Labeling: Label Mixup: NICOTINE POLACRILEX, LOZENGE, 2 mg may have potentially been mislabeled as one of the following drugs: ESTRADIOL, Tablet, 0.5 mg, NDC 00555089902, Pedigree: AD30993_11, EXP: 5/9/2014; ACAMPROSATE CALCIUM DR, Tablet, 333 mg, NDC 00456333001, Pedigree: W002973, EXP: 6/11/2014; CALCITRIOL, Capsule, 0.5 mcg, NDC 63304024001, Pedigree: W003730, EXP: 6/26/2014; ESZOPICLONE, T
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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