Drug product
Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-088-16
D-540-2013
Product summary
- Firm
- TG United, Inc.
- Event
- Event 64188
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,198 - 16 ounce bottles.
- Official record key
drug-enforcement:D-540-2013
Official wording
Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Code information: Lot# 11FQ004 Exp 05/13; Lot# 11KQ001 Exp. 09/13; Lot# 11KQ002 Exp. 09/13; Lot#11KQ003 Exp. 09/13; Lot# 12HQ010 Exp. 07/14.
Distribution pattern: FL, MS, SC, LA and TX
Derived failure modes
-
Manufacturing or process control
CGMP Deviations