Avella Recalls Hydromorphone Bags Due to Sterility Assurance Concerns
Avella of Deer Valley, Inc. is recalling 360 bags of Hydromorphone in NS due to a lack of assurance of sterility. The product was distributed nationwide.
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, and the hazard involves a lack of sterility assurance for an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
Avella of Deer Valley, Inc. Store 38 is recalling 360 bags of Hydromorphone (0.2 mg/mL) in NS 100 mL Bag. The recall is being conducted because of a lack of assurance of sterility for the product.
The affected product is prescription-only and was distributed nationwide in the United States. The specific lot number is 8/27/18 0215 22110P, with an expiration date of 12/10/2018.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Hydromorphone (0.2 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
- Affected units
- 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 (2)
- Lot # 8/27/18 0215 22110P
- Exp 12/10/2018
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
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 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
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29