Meclizine Hydrochloride Tablets Recalled for Manufacturing Temperature Control Deviations
Mckesson Medical-Surgical is recalling Meclizine Hydrochloride 25mg tablets nationwide due to manufacturing deviations involving improper temperature control. The FDA classified this as a Class II recall.
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: This is an FDA Class II recall for manufacturing deviations involving temperature control failures. While no illnesses or injuries are mentioned in the recall notice, the defect presents a potential risk to product safety and efficacy, as improper temperature control could affect drug stability.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling Meclizine Hydrochloride 25mg tablets (NDC 50268-523-15) manufactured by Avkare Inc. that were distributed nationwide in the United States. The product is a prescription oral medication.
The recall was issued due to current Good Manufacturing Practice (cGMP) deviations involving temperature abuse during the manufacturing process. Improper temperature control may affect the quality and stability of the product.
Patients and healthcare providers who have received this medication should contact Mckesson Medical-Surgical for guidance. The company has notified affected customers directly regarding lot numbers and distribution dates specific to their shipments.
The recalled product
- Product
- MECLIZINE HYDROCHLORIDE (MECLIZINE)
- Brand
- MECLIZINE HYDROCHLORIDE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
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.
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