The Recall Desk
SevereFDA (Drugs)·D-0951-2018·Announced 2018-07-25

Avella Recalls Magnesium Sulfate Bags Due to Sterility Concerns

Avella of Deer Valley, Inc. is recalling 25 bags of Magnesium Sulfate in Sodium Chloride due to potential leakage and lack of sterility assurance.

What this means for you

Illness, injury, or structural failure has been reported. 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 significant injury or property damage reports or high-risk contamination.

Plain-English summary

Avella of Deer Valley, Inc. is recalling 25 bags of MAGnesium 1gm in NS 100 mL (MAGnesium SULfate (USP) 1 gm, 0.9% Sodium Chloride (USP) 100 mL). The product is a single-dose bag with a volume of 102 mL, manufactured by Avella of Houston and intended for Salt Lake Regional Med Ctr. The specific lot number is 5/15/18 0510 169-90610P, with a beyond-use date of 8/13/2018.

The recall was initiated due to a lack of assurance of sterility, specifically caused by potential leakage of the bags. This defect poses a risk of contamination to the sterile solution.

The affected product was distributed nationwide in the USA. Consumers and healthcare facilities should stop using the recalled product and contact the manufacturer or their supplier for further instructions.

The recalled product

Product
MAGnesium 1gm in NS 100 mL (MAGnesium SULfate (USP) 1 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 102 mL. Single dose bag. For: Salt Lake Regional Med Ctr By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-906-10
Affected units
25

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 #: 5/15/18 0510 169-90610P
  • BUD 8/13/2018.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 38 recalled by Avella of Deer Valley, Inc. Store 38 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 38 products in this recall →