FDA recall D-609-2013

Pharmacia & Upjohn LLC · Class II · drug

Product

Cleocin Phosphate (clindamycin Injection), USP, a) 600 mg/4mL (150 mg/mL) ADD-Vantage Vial, b) 900 mg/6mL (150 mg/mL) ADD-Vantage Vial, Rx Only, For Intravenous Use Only, Use Only with the ADD-Vantage diluent container, Distributed by Pharmacia & Upjohn Co, Division of Pfizer Inc, NY, NY 10017, NDC a) 0009-3124-03 and b) 0009-3447-03

Reason for recall

Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent with delamination of the glass vial.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-06-04
Report date: 2013-06-26
Termination date: 2014-04-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Kalamazoo, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-609-2013