Agency classClass IIOur severity:Severe FDA (Drugs)·D-0935-2018·Announced 2018-07-25

Avella Recalls Hydromorphone Syringes Due to Sterility Assurance Concerns

Avella of Deer Valley, Inc. is recalling 275 single-dose hydromorphone syringes nationwide due to a lack of assurance of sterility caused by potential bag leakage.

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 and involves a lack of sterility assurance for an injectable drug, which poses a risk of serious infection or adverse health consequences, meeting the criteria for a Severe rating.

Plain-English summary

Avella of Deer Valley, Inc. is recalling 275 single-dose syringes of HYDROmorphone 1 mg/mL (NDC 42852-222-65). The product is identified by Lot # 5/16/18 1207 22265S and has a beyond-use date of 8/14/2018. The recall was initiated due to a lack of assurance of sterility resulting from potential leakage of the bags.

The affected syringes were distributed nationwide in the USA. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should check their inventory for the specific lot number and beyond-use date listed above. If the product is found, it should be quarantined and not administered to patients. Affected units should be returned to the recalling firm or disposed of according to local regulations.

The recalled product

Product: HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg, 0.9% Sodium Chloride (USP) QS 50 mL) Volume: 50mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC 42852-222-65
Manufacturer: Avella of Deer Valley, Inc. Store 38
Category: Drug — Injectable
Hazard: sterility
infection
Affected units: 275

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 # 5/16/18 1207 22265S
BUD 8/14/2018.

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 →

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

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Same hazard · sterility