Recalls / Class II
Class IID-525-2013
Product
BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-441-01
- Affected lot / code info
- 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.
Why it was recalled
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recalling firm
- Firm
- TG United, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 16275 Aviation Loop Dr, N/A, Brooksville, Florida 34604-6805
Distribution
- Quantity
- 16,836 bottles - 100-count.
- Distribution pattern
- FL, MS, SC, LA and TX
Timeline
- Recall initiated
- 2013-01-30
- FDA classified
- 2013-06-04
- Posted by FDA
- 2013-06-12
- Terminated
- 2016-09-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-525-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.