Recalls / Class II
Class IID-0504-2022
Product
PEPTIME Energy (caffeine 250mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.
- Affected lot / code info
- Lot #: a)19E021, b)19E022
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) 156,096 packets, b) 9,648 bottles
- 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-0504-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.