Class III · Low risk Ongoing
hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc…
Reason Presence of foreign substance
Is Hydroxyzine recalled?
24 FDA recalls mention Hydroxyzine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Hydroxyzine.
Class II · Moderate risk Terminated
HydrOXYzine Pamoate Capsules, USP, 50 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0185-0615-01
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1…
Reason Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Class II · Moderate risk Terminated
HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by Lannett…
Reason CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Class II · Moderate risk Terminated
Hydroxyzine HCl, 50mg/ml Inj, 10ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
All hydroxyzine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA…
Reason Lack of Processing Controls
Class III · Low risk Terminated
HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count…
Reason Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
Class II · Moderate risk Terminated
HYDROXYZINE HYDROCHLORIDE (STERILE WATER) (10ML VIAL) 25MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
HYDROXYZINE HYDROCHLORIDE (30ML VIAL) (STERILE WATER) 50MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Pharmacal…
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc…
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Hydroxyzine HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Terminated
Hydroxyzine hydrochloride 25 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert…
Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry…
Class II · Moderate risk Terminated
HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by…
Reason Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability…
Class II · Moderate risk Terminated
HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01
Reason Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Class II · Moderate risk Terminated
HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01
Reason Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Class II · Moderate risk Terminated
Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville…
Reason CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in…
Class II · Moderate risk Terminated
Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Distributed by Teva Pharmaceuticals USA, Sellersville…
Reason CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in…
Class II · Moderate risk Terminated
HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100…
Reason Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Class II · Moderate risk Terminated
HydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100…
Reason Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Class II · Moderate risk Terminated
HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01.
Reason Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Class II · Moderate risk Terminated
hydrOXYzine PAMOATE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00555032402.
Reason Labeling: Label Mixup: hydrOXYzine PAMOATE, Capsule, 100 mg may have potentially been mislabeled as one of the following drugs: CALCIUM CITRATE…
Class III · Low risk Terminated
HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE…
Reason Subpotent; 24 month stability test station
Class III · Low risk Terminated
HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS…
Reason Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
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