Drug product
Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-210-01
D-529-2013
Product summary
- Firm
- TG United, Inc.
- Event
- Event 64188
- Status
- Terminated
- Classification
- Class II
- Quantity
- 330158 Bulk tablets.
- Official record key
drug-enforcement:D-529-2013
Official wording
Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Code information: Lot# 12L005 Exp 10/14.
Distribution pattern: FL, MS, SC, LA and TX
Derived failure modes
-
Manufacturing or process control
CGMP Deviations