Recalls / Class II
Class IID-512-2013
Product
AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01
- Affected lot / code info
- Lot # 11D001 Exp. 03/13; Lot # 11D002 Exp. 03/13; Lot#11K003 Exp. 09/13; Lot# 12C010 Exp. 02/14.
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
- 1772 bottles per 100 count each
- 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-512-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.