FDA Drug recall D-527-2013
BroveX PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-151-01 b) 20 ml NDC 58605-151-02, Manufactured for:…
- FDA Drug
- Class II
- terminated
- Published 2013-06-12
On 2013-06-12 the FDA classified a Class II recall of BroveX PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-151-01 b) 20 ml NDC 58605-151-02, Manufactured for:… by Tg United, citing CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-527-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-30 |
| Published | 2013-06-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Tg United |
| Distribution | FL, LA, MS, SC, TX |
Product
BroveX PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-151-01 b) 20 ml NDC 58605-151-02, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737
Reason
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Identifiers
| code_info | Lot# 11AQ004 Exp. 12/12; Lot# 11AQ005 Exp. 12/12; Lot # 11AQ006 Exp. 12/12; Lot# 11AQ007 Exp. 12/12; Lot # 11BQ012…Lot# 11AQ004 Exp. 12/12; Lot# 11AQ005 Exp. 12/12; Lot # 11AQ006 Exp. 12/12; Lot# 11AQ007 Exp. 12/12; Lot # 11BQ012 Exp. 01/13; Lot# 11LQ003 Exp. 10/13; Lot# 11LQ004 Exp. 10/13; Lot# 11LQ005 Exp 10/13; Lot# 11LQ006 Exp. 10/2013. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-527-2013%22
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