D-0123-2018 Class I Terminated

Recalled by Pfizer Inc. — New York, NY

FDA drug recall D-0123-2018 was initiated by Pfizer Inc. on August 30, 2017 and is designated Class I. Reason for recall: Presence of Particulate Matter: glass particulate found in vial The recall status is terminated (terminated November 8, 2018). Affected quantity: 102,500 vials.

Recall Details

Product Type
Drugs
Report Date
December 27, 2017
Initiation Date
August 30, 2017
Termination Date
November 8, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
102,500 vials

Product Description

Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only. Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-6531-02

Reason for Recall

Presence of Particulate Matter: glass particulate found in vial

Distribution Pattern

Nationwide USA and Puerto Rico

Code Information

Lot: 632153A; Exp. 03/18