Recalls / Class II
Class IID-0472-2022
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
- Affected lot / code info
- 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
Why it was recalled
cGMP deviations
Recalling firm
- Firm
- Ultra Seal Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 521 Main St, N/A, New Paltz, New York 12561-1609
Distribution
- Quantity
- a) 147,528 bottles, b) 2,451 bottles, c) 2,492 bottles, d) 573,696 packets
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-01-24
- FDA classified
- 2022-01-31
- Posted by FDA
- 2022-02-09
- Terminated
- 2023-10-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0472-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.