Drug product
BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-441-01
D-525-2013
Product summary
- Firm
- TG United, Inc.
- Event
- Event 64188
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16,836 bottles - 100-count.
- Official record key
drug-enforcement:D-525-2013
Official wording
Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Code information: Lot# 11A002 Exp. 12/12; Lot# 11A003 Exp. 12/12; Lot # 11A004 Exp. 12/12; Lot# 11A005 Exp. 12/12; Lot# 11L003 Exp. 10/13.
Distribution pattern: FL, MS, SC, LA and TX
Derived failure modes
-
Manufacturing or process control
CGMP Deviations