FDA recall D-1160-2018

Product

Methyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multiple Dose vials, 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-1160-2018