FDA recall D-1516-2020

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

Product

Hydrochlorothiazide 50mg tablets, 14-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Accord Healthcare, Inc., Durham NC 27703; NDC 16729-0184-17

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-1516-2020