Class II ยท Moderate risk
TERPENICOL Antifungal Cream
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
National Drug Code
Is NDC 63347-0601-01 recalled?
Terpenicol · 37.5 mL in 1 BOTTLE (63347-601-01)
Yes — this exact package was recalled
1 FDA recall names the code 63347-0601-01 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.
1 of these recalls is still ongoing.
- Active ingredient
- Undecylenic Acid
- Strength
- UNDECYLENIC ACID 4.55 g/37.5mL
- Form
- Cream · Topical
- Labeler
- Blaine Labs Inc.
- Type
- Human OTC Drug
- Product code
- 63347-0601
Recalls naming this package
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
- 63347-0120 RevitaDERM Wound Care 3
- 63347-0600 Terpenicol Antifungal 1
Free recall alerts
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