FDA recall D-0141-2015

Product

Tetracycline 250 mg powder kits packaged with powder and water in separate amber glass vials, with filter, in bag, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Reason for recall

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-08-27

Report date

2014-11-05

Termination date

2018-05-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Naperville, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0141-2015