PlainRecalls
FDA Drug Moderate Class II Terminated

Labetalol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, MFG: Par Pharma, NDC 49884-122-01

Reported: June 15, 2022 Initiated: April 13, 2022 #D-1094-2022

Product Description

Labetalol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, MFG: Par Pharma, NDC 49884-122-01

Reason for Recall

cGMP deviations: Temperature abuse

Details

Units Affected
1 bottle/100 tablets
Distribution
USA nationwide.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
Labetalol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, MFG: Par Pharma, NDC 49884-122-01. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 1 bottle/100 tablets.
Why was this product recalled?
cGMP deviations: Temperature abuse
Which agency issued this recall?
This recall was issued by the FDA Drug on June 15, 2022. Severity: Moderate. Recall number: D-1094-2022.