Drug product
Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01
D-522-2013
Product summary
- Firm
- TG United, Inc.
- Event
- Event 64188
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2706 bottles of 100 count tablets
- Official record key
drug-enforcement:D-522-2013
Official wording
Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Code information: Lot# 11B002 Exp. 01/13; Lot# 11B003 Exp. 01/13; Lot # 11G007 Exp. 06/13; Lot# 11J002 Exp. 08/13; Lot# 11K002 Exp. 09/13; Lot# 12C011 Exp. 02/14.
Distribution pattern: FL, MS, SC, LA and TX
Derived failure modes
-
Manufacturing or process control
CGMP Deviations