D-528-2013 Class II Terminated
FDA drug recall D-528-2013 was initiated by TG United, Inc. on Jan 30, 2013 and is designated Class II. Reason for recall: CGMP Deviations: Products are underdosed or have an incorrect dosage regime. The recall status is terminated (terminated Sep 30, 2016).
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 12, 2013
- Initiation Date
- Jan 30, 2013
- Termination Date
- Sep 30, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Lusair Liquid, 1 PINT bottle, OTC, Marketed by: Pernix Therapeutics, Gonzales, LA 70737 NDC 23359-017-16
Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Distribution Pattern
FL, MS, SC, LA and TX
Code Information
Lot# 11AQ004 Exp. 12/12; Lot# 11AQ005 Exp. 12/12; Lot # 11AQ006 Exp. 12/12; Lot# 11AQ007 Exp. 12/12; Lot # 11BQ012 - 19728 20 mL, Exp. 01/13; Lot# 11LQ003 Exp. 10/13; Lot# 11LQ004 Exp. 10/13; Lot# 11LQ005 Exp 10/13; Lot# 11LQ006 Exp. 10/13.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-528-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026