The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0953-2018·Announced 2018-07-25

Avella Recalls Morphine Bags Due to Potential Leakage and Sterility Concerns

Avella of Deer Valley is recalling 130 bags of Morphine 1 mg/mL due to potential bag leakage and 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, particularly given the risk of sterility failure in an injectable medication.

Plain-English summary

Avella of Deer Valley, Inc. is voluntarily recalling 130 bags of MORphine 1 mg/mL (Morphine Sulfate, USP 250mg, 0.9% Sodium Chloride, USP 250 mL). The product is a single-dose bag with a volume of 255 mL, identified by NDC 42852-241-25. The specific lot affected is 2/26/18 0301 24125P, with a beyond-use date of 6/26/2018.

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 medication.

The affected product was distributed nationwide in the USA. Healthcare providers and patients should discontinue use of the affected lot and contact Avella of Deer Valley, Inc. for further instructions or replacement.

The recalled product

Product
MORphine 1 mg/mL (Morphine Sulfate, USP 250mg, 0.9% Sodium Chloride, USP 250 mL). Volume 255 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-241-25
Manufacturer
Avella of Deer Valley, Inc. Store 38
Category
Drug — Injectable
Hazard
Affected units
130

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 #:2/26/18 0301 24125P
  • BUD 6/26/2018.

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 →

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