FDA recall D-0269-2015

Product

HCG 10,000 U/ 10 mL PF Inj, 8Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5012-34

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-0269-2015