Home / Recalls / Hospira Inc., A Pfizer Company / D-0638-2017

D-0638-2017 Class I Terminated

Recalled by Hospira Inc., A Pfizer Company — Lake Forest, IL

Recall Details

Product Type
Drugs
Report Date
April 12, 2017
Initiation Date
January 24, 2017
Termination Date
April 26, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
30,880 vials

Product Description

Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in 100 mL glass vial, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6510-01

Reason for Recall

Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.

Distribution Pattern

U.S. Nationwide

Code Information

Lot # 591053A, Exp 11/1/2017

Other recalls by Hospira Inc., A Pfizer Company

  • D-0980-2017 Class III — Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, (July 6, 2017)
  • D-0898-2017 Class II — Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only (May 18, 2017)
  • D-0480-2017 Class II — METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Con (February 10, 2017)
  • Z-1682-2017 Class II — Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of (December 30, 2016)
  • D-0096-2017 Class II — Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL (September 16, 2016)
  • D-0097-2017 Class II — Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Mu (September 16, 2016)
  • D-0218-2017 Class I — Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single- (August 4, 2016)
  • Z-2790-2016 Class II — Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 1 (July 28, 2016)