FDA recall D-0270-2015

Product

2Ml HCG 10,000 U/ MB12 - 12,000 MCG/10 Ml Inj, 0.25ML (250IU), Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-7945-17

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-0270-2015