Recalls / Class II
Class IID-545-2013
Product
ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0080-30
- Affected lot / code info
- Lot# 11EQ009 Exp 04/13; Lot# 12AQ004 Exp. 12/13; Lot# 12KQ001 Exp. 09/14.
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
- 39,801 - 30 mL bottles.
- 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-545-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.