Avella Recalls Phenylephrine Bags Due to Potential Leakage
Avella of Deer Valley is recalling 200 bags of Phenylephrine 40 mg due to potential leakage that compromises sterility.
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 involves a sterile injectable drug with a risk of contamination due to leakage, which aligns with the 'Severe' criteria for significant injury risk or Class II classifications involving serious health hazards.
Plain-English summary
Avella of Deer Valley, Inc. is recalling 200 single-dose bags of Phenylephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 mL). The product is identified by NDC 42852-893-25, Lot # 5/23/18 3812 89325P, and has a beyond-use date of August 6, 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 injectable solution.
The affected product was distributed nationwide in the USA. Healthcare providers and patients should discontinue use of the recalled product and contact the manufacturer for further instructions.
The recalled product
- Product
- PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 mL) Volume: 254 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-893-25
- Manufacturer
- Avella of Deer Valley, Inc. Store 38
- Category
- Drug — Injectable
- Affected units
- 200
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 # 5/23/18 3812 89325P
- BUD 8/6/2018.
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
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