FDA recall D-1158-2018

Auro Pharmacies, Inc. · Class II · drug

Product

Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

Reason for recall

Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

Distribution

Nationwide in USA

Key facts

Status
Terminated
Initiation date
2018-08-21
Report date
2018-09-05
Termination date
2020-01-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
La Habra, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1158-2018