Class III · Low risk
Children's Cetirizine HCl Chewable Tablets 5 mg
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
National Drug Code
Is NDC 0781-5283-64 recalled?
Cetirizine Hydrochloride · 30 BLISTER PACK in 1 CARTON (0781-5283-64) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (0781-5283-06)
Yes — this exact package was recalled
1 FDA recall names the code 0781-5283-64 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
- Cetirizine Hydrochloride
- Strength
- CETIRIZINE HYDROCHLORIDE 5 mg/1
- Form
- Tablet, Chewable · Oral
- Labeler
- Sandoz Inc
- Type
- Human OTC Drug
- Product code
- 0781-5283
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
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