FDA recall D-1532-2020

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

Product

Phentermine HCL Blue Speckled tablets, 37.5 mg, packaged in a) 14-count bags (NDC 10702-0025-10) and b) 28-count bags (NDC 10702-0025-10), Rx Only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech., Inc Newtown, PA 18940.

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-1532-2020