Trinity Care Solutions Recalls Ambisome Due to Sterility Concerns
Trinity Care Solutions is recalling Ambisome 285 mg/250 mL D5W 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 product, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.
Plain-English summary
Trinity Care Solutions, operating as Franck's Lab Inc, is recalling Ambisome 285 mg/250 mL D5W. The affected product is a sterile, parenteral solution compounded by the pharmacy. The recall covers 7 units of the product, identified by Rx # 28300 and an expiration date of 02/7/14. The product was distributed in Florida.
The recall was initiated due to a lack of assurance of sterility. This decision follows concerns associated with quality control procedures observed during a recent FDA inspection. As a result, all lots of sterile products compounded by the pharmacy within their expiry dates are subject to this recall.
Consumers and healthcare providers in Florida who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement. The FDA has classified this recall as 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
- Ambisome 285 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28300, Discard After 02/7/14
- 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 # 28300
- Exp 02/7/14
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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