Class I · High risk
Tinactin (Tolnaftate 1%)
Chemical Contamination: presence of benzene
National Drug Code
Is NDC 11523-0165-03 recalled?
Tinactin · 150 g in 1 CAN (11523-0165-3)
Yes — this exact package was recalled
2 FDA recalls name the code 11523-0165-03 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
- Tolnaftate
- Strength
- TOLNAFTATE 10 mg/g
- Form
- Aerosol, Spray · Topical
- Labeler
- Bayer HealthCare LLC
- Type
- Human OTC Drug
- Product code
- 11523-0165
Recalls naming this package
Class II · Moderate risk
Tinactin (Tolnaftate 1%)
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
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
- 11523-0010 Lotrimin Daily Prevention Deo 4
- 11523-7265 See recall 4
- 11523-0072 See recall 2
- 11523-0544 See recall 2
- 11523-0777 See recall 2
- 11523-1272 See recall 2
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