Labetalol Hydrochloride Tablets Recalled for Temperature Abuse During Manufacturing
McKesson Medical-Surgical is recalling Labetalol Hydrochloride Tablets 100 mg due to temperature abuse during manufacturing that may affect drug stability. This Class II recall affects units distributed nationwide.
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 indicates potential for adverse health consequences. The cGMP deviation due to temperature abuse is a confirmed manufacturing practice violation that could affect pharmaceutical quality. However, no illnesses or adverse events have been reported.
Plain-English summary
McKesson Medical-Surgical is recalling Labetalol Hydrochloride Tablets, USP, 100 mg in 100-count bottles (manufactured by Par Pharma, NDC 49884-122-01) due to cGMP deviations caused by temperature abuse during manufacturing.
Temperature abuse during production may affect pharmaceutical quality and stability. This is a Class II recall, which means use of or exposure to the product may potentially cause adverse health consequences.
The recalled product was distributed nationwide in the United States. McKesson states that specific lot numbers cannot be identified per consignee, but customer notifications include the distribution date and dates the product may have been shipped.
No illnesses or adverse events have been reported in connection with this recall.
The recalled product
- Product
- Labetalol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, MFG: Par Pharma, NDC 49884-122-01
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Antihypertensive
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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