Trinity Care Solutions Recalls Vancomycin Due to Sterility Concerns
Trinity Care Solutions is recalling 22 units of Vancomycin 750 mg/100 mL in Florida due to quality control concerns regarding sterility assurance.
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 source text explicitly states the agency classification is Class II. According to the rubric, if the agency's own classification is FDA Class I or USDA Class I, the score is never below 4; however, the rubric also states that FDA Class II with hospitalization reports is Severe. While no hospitalizations are reported, the 'Lack of Assurance of Sterility' for a parenteral (IV) drug represents a significant risk of serious injury (sepsis), aligning with the 'Severe' criteria for significant injury reports or high-risk structural/quality defects in medical/drug contexts. Given the explicit Class II designation and the critical nature of sterility in IV drugs, a score of 4 is appropriate to reflect the potential for serious harm.
Plain-English summary
Trinity Care Solutions, operating as Franck's Lab Inc, is recalling 22 units of Vancomycin 750 mg/100 mL 0.9%NS. The affected products are identified by prescription numbers 28289 (discard after 02/5/14) and 29189 (discard after 05/23/14). The recall covers all lots of sterile products compounded by the pharmacy within their expiry dates.
The recall was initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Specifically, the agency cited a lack of assurance of sterility for the compounded products. The agency has classified this recall as Class II.
The affected products were distributed in Florida. Consumers and healthcare providers should stop using the recalled Vancomycin and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Vancomycin 750 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28289, Discard After 02/5/14; Rx # 29189, Discard After 05/23/14
- Manufacturer
- Franck's Lab Inc dba Trinity Care Solutions
- Affected units
- 22
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 (4)
- Rx # 28289
- Exp 02/5/14
- Rx # 29189
- Exp 05/23/14
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 30 recalled by Franck's Lab Inc dba Trinity Care Solutions 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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