FDA recall D-1523-2020

Calvin Scott & Company, Inc. · Class II · drug

Product

Phendimetrazine Brown/Clear Capsules, 105 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm., LLC Newtown, PA 18940; NDC 69543-0409-11

Reason for recall

CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Distribution

Nationwide within the United States

Key facts

Status
Terminated
Initiation date
2020-07-27
Report date
2020-08-26
Termination date
2024-04-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Albuquerque, NM, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1523-2020