FDA recall D-0267-2015

Perry Drug Inc. · Class II · drug

Product

HCG Low Dose 10 IU / 0.1 mL, 5 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2596-17

Reason for recall

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Distribution

Kansas and Missouri

Key facts

Status: Terminated
Initiation date: 2014-11-07
Report date: 2014-12-03
Termination date: 2015-11-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Overland Park, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0267-2015