Avella Recalls Hydromorphone Syringes Due to Sterility Concerns
Avella of Deer Valley is recalling 480 single-dose hydromorphone syringes due to potential bag leakage and lack of sterility assurance.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterility failure in an injectable drug) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Avella of Deer Valley, Inc. is recalling 480 single-dose syringes of Hydromorphone 1 mg/mL (NDC 42852-222-63). The recall is due to a lack of assurance of sterility, specifically caused by potential leakage of the bags.
The affected product is identified by Lot # 3/15/18 0954 22263M with a beyond-use date of 6/13/2018. The product was distributed nationwide in the USA.
Healthcare providers and consumers should stop using the affected syringes and contact the manufacturer or their supplier for further instructions.
The recalled product
- Product
- HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 30 mg, 0.9% Sodium Chloride (USP) QS 30 mL) Volume: 30mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC 42852-222-63
- Manufacturer
- Avella of Deer Valley, Inc. Store 38
- Category
- Drug — Injectable
- Affected units
- 480
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 #: 3/15/18 0954 22263M
- BUD 6/13/2018.
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 →Related recalls
Same manufacturer · Avella of Deer Valley, Inc. Store 38
See all →- SevereAvella Recalls Povidone Iodine Ophthalmic Solution Due to Sterility Concerns
FDA (Drugs) · 2019-10-30
- SevereAvella Recalls Bevacizumab Prefilled Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-06-05
- ModerateAvella recalls magnesium sulfate bags with incorrect barcode expiration dates
FDA (Drugs) · 2019-02-20
- ModerateAvella Recalls Labetalol Syringes Due to Incorrect Barcode Expiration Dates
FDA (Drugs) · 2019-02-20
- ModerateAvella recalls magnesium sulfate bags with incorrect barcode expiration dates
FDA (Drugs) · 2019-02-20
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- SevereAvella Recalls Hydromorphone Bags Due to Sterility Assurance Concerns
FDA (Drugs) · 2018-11-07
- SevereSCA Pharmaceuticals Recalls Hydromorphone Syringes Due to Sterility Concerns
FDA (Drugs) · 2017-11-08
- SevereAdvanced Pharma Recalls Hydromorphone Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- SevereAvella Recalls Morphine Bags Due to Sterility Assurance Concerns
FDA (Drugs) · 2018-11-07
- SevereCantrell Drug Recalls Hydromorphone Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-12-21
- HighHYDROmorphone HCl 6 mg Injectable Syringes Recalled Due to Sterility Assurance Issues
FDA (Drugs) · 2024-04-03