October 2018 FDA Recall Magnesium Sulfate In Water by Pfizer Inc.
D-0015-2019 - Correct Labeled Product Mispack
This Class II drug recall was voluntarily initiated by Pfizer Inc. on October 3, 2018 for the product Magnesium Sulfate In Water. The FDA reported the reason for recall as correct labeled product mispack. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0015-2019
Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Heparin in 0.45% Sodium Chloride for Injection (NDC 0409-7651-03, Lot 87903FW) that was found inside a case of Magnesium Sulfate in Water for Injection.
10-03-2018
10-17-2018
94,752 bags
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA and Puerto Rico
10-02-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL, 20 g Total, 500 mL Single-Dose Container bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-6729-03.
Batch or Lot Expiration Information
Lot# Lot: 87904FW, Exp. 1MAR2020
