FDA recall D-1531-2020

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

Product

Phentermine HCL White/Blue Speckled tablets, 37.5 mg, packaged in a) 7-count bags, and b) 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Lannett Company, Inc. Philadelphia, PA 19136; NDC 00527-1445-10

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-1531-2020