FDA recall D-1522-2020

Product

Phendimetrazine Yellow Tabs 35mg, packaged in a) 10-count bags (NDC 69543-0410-11) and b) 28-count bags (NDC 69543-0410-11), and c) 56-count bags (NDC 69543-0410-11) Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm, LLC.

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-1522-2020