RecallDepth
Class II Terminated

Losartan Potassium Tablets USP 25 mg 30 count bottle NDC 60429-316-30 Rx only GSMS Incorporated

Company
Golden State Medical Supply Inc.
Recall Initiated
May 1, 2019
Posted
May 29, 2019
Recall Number
D-1282-2019
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
11,668 HDPE bottles
Firm Location
Camarillo, CA, United States

Reason for Recall

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Distribution

IL, MI, MN, PA, TN, TX. Two (2) US government and one (1) Veterans Affairs accounts. No foreign accounts.

Lot / Code Info

GS017981 exp 02/2020, GS016958 exp 02/2020, GS017341 exp 02/2020

More recalls by Golden State Medical Supply Inc.

View all recalls by this company →

Other recent Class II Drug recalls