FDA recall D-0048-2017

Product

HEPARIN Sodium Inj., USP, 5,000 USP Heparin Units per 5 mL Total Volume in a syringe, NOT FOR LOCK FLUSH, 1,000 USP Heparin Units per mL, Rx only, PharMEDium, Product code 2K1925.

Reason for recall

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-07-17

Report date

2016-10-19

Termination date

2017-06-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0048-2017