The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0131-2019·Announced 2018-11-07

Avella Recalls Morphine Bags Due to Sterility Assurance Concerns

Avella of Deer Valley is recalling 1,360 bags of Morphine in NS due to a lack of assurance of sterility. The product was distributed nationwide.

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 significant injury or property damage reports, or high-risk scenarios without confirmed fatalities.

Plain-English summary

Avella of Deer Valley, Inc. is recalling 1,360 bags of Morphine (1 mg/mL) in NS 100 mL Bag. The recall is being conducted due to a lack of assurance of sterility. The affected product is prescription-only and was distributed nationwide in the U.S.A.

The specific lots involved are Lot # 7/10/18 0415 24110P (Exp 11/07/2018) and Lot # 7/25/18 0247 24110P (Exp 11/22/2018). The product was manufactured by Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38.

Healthcare providers and patients should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Morphine (1 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
Manufacturer
Avella of Deer Valley, Inc. Store 38
Category
Drug — Injectable
Hazard
Affected units
1,360

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 # 7/10/18 0415 24110P
  • Exp 11/07/2018
  • 7/25/18 0247 24110P
  • Exp 11/22/2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

Related recalls

Same manufacturer · Avella of Deer Valley, Inc. Store 38

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Same hazard · sterility

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