Hydroxyzine Pamoate Capsules Recalled Due to Temperature Abuse During Manufacturing
McKesson Medical-Surgical is recalling Hydroxyzine Pamoate Capsules due to cGMP deviations from temperature abuse during manufacturing, which may affect drug stability and potency.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification combined with a risk-of-harm prescription drug where temperature abuse may compromise stability and efficacy. No illnesses or injuries have been reported in the source text, limiting the score per the rubric.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Hydroxyzine Pamoate Capsules, USP, 50 mg supplied in 100-count bottles. The nationwide recall was issued due to cGMP (current Good Manufacturing Practice) deviations involving temperature abuse during manufacturing by Sandoz Pharma. Temperature abuse may compromise the stability and potency of the drug.
Hydroxyzine Pamoate is a prescription antihistamine and anxiolytic agent. McKesson Medical-Surgical was unable to identify specific lot numbers affected by the temperature deviation but has provided customers with shipment dates that may include impacted product.
Patients currently taking Hydroxyzine Pamoate should contact their pharmacist or healthcare provider to determine if their medication supply was affected. Do not discontinue medication without consulting a healthcare provider. Pharmacies and healthcare providers should review the recall notice for shipment dates associated with potentially impacted product.
The recalled product
- Product
- HYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE)
- Brand
- HYDROXYZINE PAMOATE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (2)
- 0301850613014
- 0301850674015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 130 products in this recall →Related recalls
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