FDA recall D-1395-2015

Product

Dexamethasone 24 mg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Reason for recall

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Distribution

Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY

Key facts

Status

Terminated

Initiation date

2015-06-15

Report date

2015-09-02

Termination date

2018-04-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chatham, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1395-2015