Avella Recalls Ephedrine Syringes Due to Potential Sterility Issues
Avella of Deer Valley is recalling specific lots of ePHEDrine 50mg syringes because bags may leak, compromising sterility.
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 (sterile injection) where injury has not yet been reported, fitting the High severity criteria for potential contamination without confirmed illness.
Plain-English summary
Avella of Deer Valley, Inc. is recalling 5,400 syringes of ePHEDrine 50mg (Ephedrine Sulfate, USP) in 0.9% Sodium Chloride. The recall involves specific lots with expiration dates of July 3, 2018, and September 7, 2018, which were distributed nationwide in the United States.
The recall was initiated due to a lack of assurance of sterility. The source text indicates that the bags containing the medication may leak, which poses a risk of contamination.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, it should be discontinued and returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- ePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride, USPQS 10mL. 10 mL-Sterile use dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-61
- Manufacturer
- Avella of Deer Valley, Inc. Store 38
- Category
- Drug — Injectable Medication
- Affected units
- 5,400
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 (9)
- Lot # 3/5/18 8055 80561S
- 3/5/18 0514 80561S
- 3/5/18 5259 80561S
- 3/5/18 6131 80561S
- 3/5/18 5641 80561S
- BUD 7/3/2018
- 5/10/18 1312 80561S
- 5/10/18 1322 80561S
- BUD 9/7/2018
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.
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