URGENT: Hospira, Inc. Issues Voluntary Recall of Ketorolac Tromethamine Inj., USP

Transcription

1 July 1, 2015 URGENT: Issues Voluntary Recall of Dear ASD Healthcare Customer: is voluntarily recalling multiple product lists and lots of. This recall action is being initiated due to the potential for particulate in glass vials containing Ketorolac. Through visual inspection of retained product, three lots displayed visible, floating particulate within glass fliptop vials. The particulate was identified as calcium-ketorolac crystals. The remaining lots are being recalled out of an abundance of caution. Please check your inventory and immediately stop use and quarantine any affected product. 30 mg (30 mg/ml), 1 ml Fill, Single- Dose Product NDC Number Lot* 30 mg (30 mg/ml), 1 ml Fill, Single- Dose, NOVAPLUS 60 mg (30 mg/ml), 2 ml Fill, Single- Dose 60 mg (30 mg/ml), 2 ml Fill, Single- Dose, NOVAPLUS Reference Table 1 on following page Expiration Date* Reference Table 1 on following page *Please refer to the following pages for the full listing of lot numbers and expiration dates. Return Instructions: Complete the reply form and return it to the fax number or address on the form, even if you do not have the affected product. Return affected product to Stericycle. To obtain a return label or for additional assistance, contact Stericycle at (M-F 8am to 5pm ET) or go online at For Clinical Inquiries: Hospira Contact Contact Information Areas of Support Hospira Global Complaint Management Hospira Medical Communications (M-F 8am to 5pm CT) or productcomplaintspp@hospira.com (Available 24/7) or medcom@hospira.com To report adverse events or product complaints Medical inquiries For the full recall notice and return instructions, please view the attached documents in the following pages.

2 Table 1 Product NDC Number Lot* DK DK DK DK DK DK Expiration Date 01AUG mg (30 mg/ml), 1 ml Fill, Single-dose Table 1 continued on next page DK DK DK DK DK DK DK DK DK DK DK DK DK DK DK DK DK DK DK DK DK DK DK DK DK DK DK DK DK DK DK 01AUG SEP FEB FEB FEB MAR MAR JUN JUN OCT OCT _01_03AS_V of 6 FA (3)

3 Table 1 continued Product NDC Number Lot* Expiration Date DK 01AUG DK 01AUG DK 01AUG DK 01SEP mg (30 mg/ml), 1 ml Fill, Single-dose, NOVAPLUS DK 01SEP DK DK DK 01MAR DK 01MAR DK DK DK 01AUG DK 01AUG DK 01SEP DK DK 01JAN DK 01MAY mg (30 mg/ml), 2 ml Fill, Single-dose DK 01JUN DK 01OCT DK 01OCT DK 01OCT DK 01OCT DK 01OCT DK 01OCT DK 01OCT mg (30 mg/ml), 2 ml Fill, Single-dose, NOVAPLUS DK *Note: The lot number may be followed by additional numbers from 01 to _01_04AS_V of 6 FA (3)

4 5347_01_01AS_V1.1

5 5347_01_02AS_V1.1

6 Urgent Drug Recall Reply Form Response Required Check your inventory and complete the information below, even if you do not have the affected product. Please be sure to include all pages of the Urgent Drug Recall Reply Form when faxing or ing. Failure to complete all sections of this page may result in improper, delayed or denied credit. Fax the completed form to or the completed form to The return label provided in this notification is for single use only, please DO NOT reproduce. Please visit to request additional labels for returning product. If you have not received a return label or require additional assistance contact Stericycle at (M-F, 8am to 5pm ET). Required Information Business Name Phone Number Address/City/State/ZIP DEA # Hospira Customer Number (ship to #) if applicable Your reference # (e.g. PO, Debit Memo or Invoice #) Completed by: Printed Name/Signature/Date I have NO affected product (fill out and return this form to Stericycle at the fax/ above). YES, I have affected product (fill out and return this form to Stericycle via the fax/ above and return the product per the instructions on the return label). If yes, do you intend to return the affected product? YES NO If affected product is not being returned, please explain: SAMPLE Have you distributed the product further? YES NO If yes, have you notified your customers? YES NO (if no, explain below) 5347_01_05AS_V1.1 CID/SEQ 5 of 6 FA (3)

7 Urgent Drug Recall Reply Form Response Required Check your inventory and complete the information below if you have affected product to return. Please be sure to include all pages of the Urgent Drug Recall Reply Form when faxing or ing. Failure to complete all sections of this page may result in improper, delayed or denied credit. Customer Name Customer Number NDC and Lot Number Quantity to be returned Wholesaler/Distributor Name If you purchased from Wholesalers/Distributors include name, address, city, state, ZIP, quantity from each, and invoice number. If you purchased directly from Hospira leave this section blank. PO, debit memo or invoice SAMPLE 5347_01_06AS_V1.1 CID/SEQ 6 of 6 FA (3)