Gentamicin Syringes Recalled for Lack of Sterility Assurance
Walgreens Infusion Services is recalling 27 prefilled Gentamicin syringes in Texas due to a lack of assurance of 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 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 agency classification is FDA Class II, and the hazard involves a lack of sterility assurance for an injectable drug, which poses a significant risk of infection or injury, meeting the criteria for a Severe rating.
Plain-English summary
Walgreens Infusion Services is recalling 27 prefilled syringes of Gentamicin 14.4 mg/sodium chloride 0.9% (30 mL). The product is prescription-only and was compounded by Option Care 148 in San Antonio, Texas. The recall was initiated because of a lack of assurance of sterility.
The affected product was distributed in Texas. The recall covers all lots within their expiry dates. No specific lot numbers or dates are provided in the source text.
Consumers and healthcare providers should stop using the recalled syringes and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
- Manufacturer
- Walgreens Infusion Services
- Category
- Drug — Injectable
- Hazard
- Affected units
- 27
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 (1)
- All lots within expiry.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 33 recalled by Walgreens Infusion Services 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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