The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1282-2016·Announced 2016-07-20

Pharmakon Recalls Magnesium Sulfate Bags Due to Sterility Concerns

Pharmakon Pharmaceuticals is recalling 72 bags of Magnesium Sulfate in Lactated Ringers due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

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 source text identifies the agency classification as Class II. According to the rubric, an FDA Class II recall involving a sterile compounded product (implying significant injury risk from lack of sterility) maps to a score of 4 (Severe), as it exceeds the criteria for 'High' which typically applies to theoretical risks or specific pathogens without reported illness.

Plain-English summary

Pharmakon Pharmaceuticals, Inc. is recalling 72 bags of Magnesium Sulfate 50 GM in Lactated Ringers 500 mL. The recall is being conducted because of a lack of assurance of sterility for the sterile compounded products. The affected products are prescription-only and were compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana.

The recall covers all sterile compounded products within their expiry dates. The distribution pattern indicates the products were shipped nationwide, as well as to specific VA/DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia.

Consumers and healthcare providers should check their inventory for the specific NDC 45183-0407-03 and discontinue use of the affected bags. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Magnesium Sulfate 50 GM in Lactated Ringers 500 mL bag; Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0407-03
Manufacturer
Pharmakon Pharmaceuticals, Inc.
Category
Drug — Sterile Compounded Product
Hazard
Affected units
72

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 (1)

  • All Sterile Compounded Products within Expiry

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 88 recalled by Pharmakon Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 88 products in this recall →

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