FDA recall D-1546-2014

Product

Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869.

Reason for recall

Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination.

Distribution

NY, NJ, and Puerto Rico

Key facts

Status

Terminated

Initiation date

2014-06-25

Report date

2014-08-27

Termination date

2016-09-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Randolph, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1546-2014