Home / Recalls / Hospira Inc., A Pfizer Company / D-0898-2017

D-0898-2017 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
June 21, 2017
Initiation Date
May 18, 2017
Termination Date
May 2, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
(720503A): 43,200 vials, (720603A): 400 vials

Product Description

Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04

Reason for Recall

GMP Deviation; A foreign stopper was observed during packaging of a lot of product.

Distribution Pattern

Nationwide, Canada and Singapore

Code Information

720503A, 720603A (Canada only)

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-0480-2017 Class II — METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Con (February 10, 2017)
  • D-0638-2017 Class I — Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - N (January 24, 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)