Recalls / Class III

Class IIID-0854-2016

Product

Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.

Affected lot / code info

Lot #: 42-335-DK, Exp 1JUN2016; 48-128-DK, 48-129-DK, 48-261-DK, 48-262-DK, 48-351-DK, Exp 1DEC2016; 52-361-DK, Exp 1APR2017; note that the lot number may be followed by numbers from 01 to 99.

Why it was recalled

Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.

Recalling firm

Firm

Hospira Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579

Distribution

Quantity

715,200 vials

Distribution pattern

Nationwide, Puerto Rico, United Arab Emirates, Israel, Kuwait, Bahrain, and Trinidad & Tobago

Timeline

Recall initiated

2016-03-23

FDA classified

2016-05-16

Posted by FDA

2016-05-25

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0854-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.