Vann Healthcare Pharmacy Recalls Tri-mix #4 Due to Sterility Concerns
Vann Healthcare Pharmacy is recalling Tri-mix #4 vials because an FDA inspection found deficiencies that raise concerns about the pharmacy's ability to consistently 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. According to the rubric, FDA Class II recalls with potential for serious adverse health consequences (such as sterility failures in injectable drugs) are categorized as Severe.
Plain-English summary
Vann Healthcare Services Inc is recalling Tri-mix #4 (Papaverine 30 mg, Phentolamine 1 mg, Prostaglandin-1 10 mcg/mL), packaged in 10 mL sterile glass vials. The recall involves 7 vials distributed in Kentucky. Specific lot numbers include 04302014@1, 05072014@4, 05212014@2, 06192014@2, 08072014@4, and 10022014@4.
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. The agency classification for this recall is Class II.
Consumers who have purchased or received these specific vials should stop using them and contact their healthcare provider or the pharmacy for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Tri-mix #4 (Papaverine 30 mg, Phentolamine 1 mg, Prostaglandin-1 10 mcg/mL), packaged in 10 mL sterile glass vials, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
- Manufacturer
- Vann Healthcare Services Inc
- Affected units
- 7
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 (7)
- Lot #s: 04302014@1
- 5 mL vial 05072014@4
- 10 mL vial 05212014@2
- 10 mL vial 06192014@2
- 10 mL vial 08072014@4
- 5 mL vial 10022014@4
- 10 mL split into 2 - 5 mL vials for two different patients
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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