Class II · Moderate risk
Teva Hydroxyzine Pamoate Capsules
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
National Drug Code
Is NDC 0555-0324-02 recalled?
Hydroxyzine Pamoate · 100 CAPSULE in 1 BOTTLE (0555-0324-02)
Yes — this exact package was recalled
2 FDA recalls name the code 0555-0324-02 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 Pamoate
- Strength
- HYDROXYZINE PAMOATE 100 mg/1
- Form
- Capsule · Oral
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Type
- Human Prescription Drug
- Product code
- 0555-0324
Recalls naming this package
Class II · Moderate risk
hydrOXYzine PAMOATE
Labeling: Label Mixup: hydrOXYzine PAMOATE, Capsule, 100 mg may have potentially been mislabeled as one of the following drugs: CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium), NDC 00904506260, AD46257_43, EXP: 5/15/2014; guaiFENesin ER, Tablet, 600 mg, NDC 45802049878, Pedigree: W002734, EXP: 6/6/2014; guaiFENesin ER, Tablet, 600 mg, NDC 45802049878, Pedigree: W003689, EXP: 6/26/20
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
- 0555-0972 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 4
- 0555-9123 Jolessa 3
- 0555-0777 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 2
- 0555-0808 See recall 2
- 0555-0899 Estradiol 2
- 0555-1054 Claravis 2
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