Class II · Moderate risk
Azelaic Acid Gel
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
National Drug Code
Is NDC 68462-0626-52 recalled?
azelaic acid · 1 TUBE in 1 CARTON (68462-626-52) / 50 g in 1 TUBE
Yes — this exact package was recalled
3 FDA recalls name the code 68462-0626-52 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
- azelaic acid
- Strength
- AZELAIC ACID .15 g/g
- Form
- Gel · Topical
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Type
- Human Prescription Drug
- Product code
- 68462-0626
Recalls naming this package
Class II · Moderate risk
Azelaic Acid Gel
CGMP Deviations: Market complaints received for gritty texture (grainy)
Class II · Moderate risk
Glenmark
CGMP Deviations
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
- 68462-0164 Carvedilol 5
- 68462-0165 Carvedilol 4
- 68462-0248 See recall 4
- 68462-0357 Potassium Chloride 4
- 68462-0562 Diltiazem Hydrochloride 4
- 68462-0249 See recall 3
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