Trinity Care Solutions Recalls Compounded Cubicin Due to Sterility Concerns
Trinity Care Solutions is recalling 7 units of compounded Cubicin in Florida 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in a parenteral (intravenous) product, which poses a significant risk of serious injury or hospitalization if contaminated.
Plain-English summary
Trinity Care Solutions, operating as Franck's Lab Inc, is recalling 7 units of Cubicin 486 mg/100 mL 0.9%NS compounded for parenteral use. The affected product is identified by Rx # 29038 and has an expiration date of 05/20/14. The recall is limited to distribution in Florida.
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 agency has classified this recall as Class II, indicating a situation that might cause temporary or medically reversible adverse health consequences.
Patients who have received this specific compounded medication should contact their healthcare provider or pharmacist for guidance. The recall covers all lots of sterile products compounded by the pharmacy within the expiry period.
The recalled product
- Product
- Cubicin 486 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, RX # 29038, Discard After 05/20/2014
- Manufacturer
- Franck's Lab Inc dba Trinity Care Solutions
- Hazard
- 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 (2)
- Rx # 29038
- Exp 05/20/14
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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