Home / Recalls / Hospira Inc., A Pfizer Company / D-0097-2017

D-0097-2017 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
October 19, 2016
Initiation Date
September 16, 2016
Termination Date
July 31, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4768 vials

Product Description

Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50.

Reason for Recall

Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot #: 59310DD, Exp 1NOV2017

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)
  • 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-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)