Drug product
BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-311-16
D-519-2013
Product summary
- Firm
- TG United, Inc.
- Event
- Event 64188
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22,721 - 16 ounce bottles
- Official record key
drug-enforcement:D-519-2013
Official wording
Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Code information: Lot# 12B001 Exp. 01/14; Lot# 12B001 Exp. 01/14; Lot# 12B002 Exp 01/14; Lot# 12F013 Exp. 05/14; Lot# 12F013 Exp. 05/14.
Distribution pattern: FL, MS, SC, LA and TX
Derived failure modes
-
Manufacturing or process control
CGMP Deviations