Agency classClass IIOur severity:Severe FDA (Drugs)·D-0015-2019·Announced 2018-10-17

Magnesium Sulfate Injection Recalled Due to Mispackaged Heparin Unit

Pfizer is recalling 94,752 bags of Magnesium Sulfate in Water for Injection because a single unit of Heparin was found inside a case.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for adverse health consequences (such as administering the wrong drug) are rated as Severe (4).

Plain-English summary

Pfizer Inc. is recalling 94,752 bags of Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL, 20 g Total, 500 mL Single-Dose Container. The recall is due to a confirmed report of a single unit of properly labeled Heparin in 0.45% Sodium Chloride for Injection (NDC 0409-7651-03, Lot 87903FW) found inside a case of the Magnesium Sulfate product.

The affected product is identified by Lot 87904FW with an expiration date of 1MAR2020. The product was distributed nationwide in the USA and Puerto Rico. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and patients should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be quarantined and not administered. Consumers should contact their healthcare provider for further instructions.

The recalled product

Product: MAGNESIUM SULFATE IN WATER (MAGNESIUM SULFATE IN WATER)
Brand: MAGNESIUM SULFATE IN WATER
Manufacturer: Pfizer Inc.
Category: Drug — Injection
Hazard: mis-labeling
wrong-drug-administration
Affected units: 94,752

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot: 87904FW
Exp. 1MAR2020

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same brand · MAGNESIUM SULFATE IN WATER

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Hospira Recalls Magnesium Sulfate Injection Bags Due to Incorrect Barcode Labeling
FDA (Drugs) · 2016-02-24
Low
Hospira Recalls Magnesium Sulfate Injection Due to High Potency
FDA (Drugs) · 2012-06-27

Same manufacturer · Pfizer Inc.

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