The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0020-2018·Announced 2017-11-01

Banner Pharmacy Recalls Magnesium Sulfate IV Bags Due to Sterility Concerns

Banner Pharmacy Services is recalling 7,578 bags of Magnesium sulfate 10 Gm in Lactated Ringer's due to a lack of assurance of sterility.

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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric for drug recalls involving potential adverse health consequences.

Plain-English summary

Banner Pharmacy Services, LLC is recalling 7,578 bags of Magnesium sulfate 10 Gm added to Lactated Ringer's 250 mL bags. The product is prescription-only and was distributed nationwide within the United States. The recall involves multiple lots with expiration dates ranging from October 20, 2017, to February 23, 2018.

The recall was initiated due to a lack of assurance of sterility. This classification indicates a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and patients should discontinue use of the affected lots and contact Banner Pharmacy Services for further instructions or replacement.

The recalled product

Product
Magnesium sulfate 10 Gm added to Lactated Ringer's 250 mL bags, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025003201
Manufacturer
Banner Pharmacy Services, LLC
Category
Drug — IV Compounded Medication
Hazard
Affected units
7,578

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 (20)

  • Lot #: 042017S4
  • Exp 10/20/2017
  • 042517S2
  • 10/25/2017
  • 042617S3
  • Exp 10/26/2017
  • 050317S2
  • Exp 11/2/2017
  • 050517S3
  • Exp 11/4/2017
  • 051217S2
  • Exp 11/11/2017
  • 051917S1
  • Exp 11/18/2017
  • 052917S4
  • Exp 11/28/2017
  • 061317S5
  • Exp 12/13/2017
  • 061617S1
  • Exp 12/16/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 recalled by Banner Pharmacy Services, LLC 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 14 products in this recall →

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