Hydroxyzine Pamoate
FDA Recall NDC 0185-0613
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 1 recorded enforcement report(s) associated with Hydroxyzine Pamoate (NDC 0185-0613). A significant event, classified as Class II, was initiated on Apr 13, 2022 by Sandoz Inc. The reported reason for this action was: "cGMP deviations: Temperature abuse"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
cGMP deviations: Temperature abuse
Apr 13, 2022
Jun 15, 2022
30 bottles/100 capsules per bottle
Recall Profile & Regulatory Data
Event ID
89646
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Nov 30, 2023
Product Description
HydrOXYzine Pamoate Capsules, USP, 50 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0185-0615-01
Batch or Lot Expiration Information
Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Affected Packages Involved in this Recall
0185-0674-10Product
0185-0674-05Product
0185-0674-01Product
0185-0615-10Product
0185-0615-05Product
0185-0615-01Product
0185-0613-10Product
0185-0613-05Product
0185-0613-01Product
0185-0676-10Product
0185-0676-05Product
0185-0676-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
