Trinity Care Solutions Recalls Vancomycin Due to Sterility Concerns
Trinity Care Solutions is recalling 16 units of Vancomycin 750 mg/150mL D5W due to quality control concerns regarding sterility assurance identified during an FDA inspection.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text identifies the recall as FDA Class II and cites a lack of assurance of sterility for a parenteral (intravenous) product. Per the rubric, FDA Class II recalls involving significant injury risks or structural defects are classified as Severe (Score 4).
Plain-English summary
Trinity Care Solutions, operating as Franck's Lab Inc, is recalling 16 units of Vancomycin 750 mg/150mL D5W. The product is intended for parenteral use only and was distributed in Florida. The specific lot is identified by Rx # 28878 with an expiration date of 05/16/14.
The recall was initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. The agency has cited a lack of assurance of sterility as the primary reason for the action. All lots of sterile products compounded by the pharmacy within their expiry dates are subject to this recall.
Consumers and healthcare providers should stop using the affected product immediately. The recall is classified as FDA Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Vancomycin 750 mg/150mL D5W,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28878, Discard After 05/16/14
- Manufacturer
- Franck's Lab Inc dba Trinity Care Solutions
- Category
- Drug — Antibiotic
- Affected units
- 16
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 (2)
- Rx # 28878
- Exp 05/16/14
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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