Trinity Care Solutions Recalls Cefepime Sterile Compounds Due to Sterility Concerns
Trinity Care Solutions is recalling 24 units of Cefepime 2 gm/100 mL D5W in Florida due to quality control concerns regarding sterility assurance.
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 explicitly states the agency classification is Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterile products where sterility assurance is compromised.
Plain-English summary
Trinity Care Solutions, operating as Franck's Lab Inc, is recalling 24 units of Cefepime 2 gm/100 mL D5W. The affected product is intended for parenteral use only and was distributed in Florida. The recall covers specific prescription lots: Rx # 28288 (Discard After 02/4/14), Rx # 29176 (Discard After 05/21/14), and Rx # 28829 (Discard After 05/17/14).
The recall was initiated due to a lack of assurance of sterility. This action follows concerns associated with quality control procedures observed during a recent FDA inspection. The source text notes that 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 Cefepime products and contact their pharmacist or the recalling firm for further instructions. The FDA has classified this recall as Class II.
The recalled product
- Product
- Cefepime 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28288, Discard After 02/4/14; Rx # 29176, Discard After 05/21/14; Rx # 28829, Discard After 05/17/14
- Manufacturer
- Franck's Lab Inc dba Trinity Care Solutions
- Hazard
- Affected units
- 24
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 (6)
- Rx # 28288
- Exp 02/4/14
- Rx # 29176
- Exp 05/21/14
- Rx # 28829
- Exp 05/17/14
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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