Banner Pharmacy Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
Banner Pharmacy Services is recalling ephedrine sulfate syringes because the company cannot ensure the product is sterile.
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 the hazard involves a lack of assurance of sterility in a parenteral medication, which poses a significant risk of infection or serious injury.
Plain-English summary
Banner Pharmacy Services, LLC is recalling 972 syringes of ePHEDrine sulfate 50 mg/10 ml in 0.9% Sodium Chloride. The recall was initiated because the company lacks assurance of the sterility of the product.
The affected product is a prescription-only medication manufactured by Banner Health Compounding Pharmacy in Chandler, Arizona. The recall covers specific lots with expiration dates ranging from October 2017 to November 2017. The product was distributed nationwide within the United States.
Consumers and healthcare providers should stop using the affected syringes and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- ePHEDrine sulfate 50 mg/10 ml syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025024801
- Manufacturer
- Banner Pharmacy Services, LLC
- Affected units
- 972
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 (8)
- Lot #: 072717S1
- Exp 10/25/2017
- 080217S1
- 10/31/2017
- 081517S2
- Exp 11/13/2017
- 082917S1
- Exp 11/27/2017.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Banner Pharmacy Services, LLC 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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