Vann Healthcare Recalls Lidocaine Syringes Due to Sterility Concerns
Vann Healthcare Services is recalling Lidocaine 4% syringes because an FDA inspection found deficiencies in the facility's ability to assure 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of non-sterile medical products.
Plain-English summary
Vann Healthcare Services Inc is recalling 900 syringes of Lidocaine 4% Syr (PF) Rx, 1 mL packaged in 3 mL syringes. The affected lots are 06174A, 07214B, and 08154A. The product was distributed in Kentucky.
The recall was initiated following a recent FDA inspection of the Vann Healthcare Services facility. The inspection revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure the sterility of its products.
Consumers and healthcare providers who have this product should stop using it and contact Vann Healthcare Services for further instructions.
The recalled product
- Product
- Lidocaine 4% Syr (PF) Rx, 1 mL packaged in 3 mL syringes, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
- Manufacturer
- Vann Healthcare Services Inc
- Category
- Drug — Pharmacy Compounded
- Hazard
- Affected units
- 900
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 (3)
- Lot #s: 06174A
- 07214B
- and 08154A.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 recalled by Vann Healthcare Services Inc 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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