Drug product
DBI 357 Super Magnum Quick Energy Stimulant (caffeine 200mg) tablets, packaged in a) 36-count bottles, b) 100-count bottles, c) 500-count bottles, and d) 3-count packets, Marketed by: DBI Distribution A Division of King Richard Promotions, Inc. P.O. Box 78546, Indianapolis, IN 46270
D-0472-2022
Product summary
- Event
- Event 89464
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 147,528 bottles, b) 2,451 bottles, c) 2,492 bottles, d) 573,696 packets
- Official record key
drug-enforcement:D-0472-2022
Official wording
Reason: cGMP deviations
Code information: Lot #: a) C19065, Exp. Date 03/2022; F19081, Exp. Date 06/2022; 19H083, Exp. Date 08/2022; b) H19083, 1H9083, Exp. Date 08/2022; c) 19F081, Exp. Date 06/2022; 19083H, Exp. Date 08/2022; d) 19C065, Exp. Date 03/2022; 19081F, Exp. Date 06/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP deviations