PlainRecalls
FDA Drug Moderate Class II Terminated

Naltrexone Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, MFG: Mallinckrodt Inc., NDC 0406-1170-03

Reported: June 15, 2022 Initiated: April 13, 2022 #D-1039-2022

Product Description

Naltrexone Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, MFG: Mallinckrodt Inc., NDC 0406-1170-03

Reason for Recall

cGMP deviations: Temperature abuse

Details

Units Affected
4 bottles/30 tablets per bottle
Distribution
USA nationwide.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
Naltrexone Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, MFG: Mallinckrodt Inc., NDC 0406-1170-03. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 4 bottles/30 tablets per bottle.
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-1039-2022.