The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0768-2017·Announced 2017-05-24

Key Pharmacy Recalls Magnesium Sulfate Injections Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling specific lots of Magnesium Sulfate 50% injections because the firm cannot assure the sterility of the product.

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 explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall involving a sterile compounded drug where sterility assurance is lacking is classified as Severe (Score 4), as it poses a significant risk of infection or serious injury.

Plain-English summary

Key Pharmacy and Compounding Center is recalling specific lots of Magnesium Sulfate 50% Injection, 10 mL Multiple Dose Vials. The recall is being conducted because the firm lacks assurance of the sterility of these compounded drugs. The affected product is a prescription-only medication prepared by the pharmacy.

The recall covers two specific lots: Lot # t02-06-2017@106 with an expiration date of 5/8/2017, and Lot # 02-13-2017@75 with an expiration date of 5/14/2017. The source text indicates that the product was distributed nationwide in the U.S.A., as well as in Australia and Canada.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled lots, it should be discontinued from use and returned to the pharmacy or disposed of according to local regulations. The FDA classifies this as a Class II recall.

The recalled product

Product
MAGNESIUM SO4 10ML MDV 50% INJ, Injection, 50%, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Sterile Drug
Hazard
Affected units
3

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 (4)

  • Lot # t02-06-2017@106
  • Exp 5/8/2017
  • 02-13-2017@75
  • Exp 5/14/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 79 recalled by Key Pharmacy and Compounding Center 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 79 products in this recall →

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