Trinity Care Solutions Recalls Compounded Cubicin Due to Sterility Concerns
Trinity Care Solutions is recalling compounded Cubicin 700 mg/100 mL due to quality control concerns 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 involves a lack of assurance of sterility in a parenteral (IV) product, which poses a significant risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
Trinity Care Solutions, operating as Franck's Lab Inc, is recalling 7 units of compounded Cubicin 700 mg/100 mL 0.9%NS. The product was distributed in Florida and is identified by Rx # 29083 with an expiration date of 05/21/14.
The recall was initiated due to a lack of assurance of sterility. This decision follows concerns regarding quality control procedures observed during a recent FDA inspection. The agency classifies this as a Class II recall.
Patients who received this medication should contact their healthcare provider or pharmacy for guidance on next steps.
The recalled product
- Product
- Cubicin 700 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29083, Discard After 05/21/14
- Manufacturer
- Franck's Lab Inc dba Trinity Care Solutions
- 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 # 29083
- Exp 05/21/14
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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