Class II · Moderate risk
HydrOXYzine HYDROCHLORIDE SYRUP
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
National Drug Code
Is NDC 54838-0502-80 recalled?
Hydroxyzine Hydrochloride · 473 mL in 1 BOTTLE, PLASTIC (54838-502-80)
Yes — this exact package was recalled
1 FDA recall names the code 54838-0502-80 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
- Hydroxyzine Hydrochloride
- Strength
- HYDROXYZINE DIHYDROCHLORIDE 10 mg/5mL
- Form
- Solution · Oral
- Labeler
- Lannett Company, Inc.
- Type
- Human Prescription Drug
- Product code
- 54838-0502
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
- 54838-0011 See recall 1
- 54838-0501 Haloperidol 1
- 54838-0548 See recall 1
- 54838-0550 See recall 1
- 54838-0566 See recall 1
Free recall alerts
Know the day your medication is recalled
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