Class III · Low risk
hydrOXYzine Hydrochloride Oral Solution
Presence of foreign substance
Teva Hydroxyzine Pamoate Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
Cause type: Unapproved drug
The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.
What was recalled
Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Distributed by Teva Pharmaceuticals USA, Sellersville, PA. NDC 0555-0324-02
Affected NDC
0555-0324-02
Compare with the code on your package — it is the most precise check available.
Drug: Hydroxyzine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Hydroxyzine Pamoate NDC 00555-0324 |
100 mg/1 | Capsule Oral |
Teva Pharmaceuticals USA, Inc. | Rx |
- Recalling firm
- Teva Pharmaceuticals USA
- NDC code
- 0555-0324-02
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1093-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Hydroxyzine recalls
See all
Class II · Moderate risk
HydrOXYzine Pamoate Capsules
cGMP deviations: Temperature abuse
Class II · Moderate risk
Hydroxyzine Hydrochloride Oral Solution
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Class II · Moderate risk
HydrOXYzine HYDROCHLORIDE SYRUP
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Class II · Moderate risk
Hydroxyzine HCl
Lack of Assurance of Sterility
Other recalls by Teva Pharmaceuticals USA
All 2014 recalls
Class II · Moderate risk
traZODone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk
Claravis (isotretinoin capsule, USP)
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
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