Trinity Care Solutions Recalls Unasyn Due to Sterility Concerns
Trinity Care Solutions is recalling 60 units of Unasyn (ampicillin/sulbactam) in Florida due to quality control concerns regarding sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a sterile injectable medication with a lack of assurance of sterility, 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 60 units of Unasyn (ampicillin/sulbactam) 1.5 gm/100 mL 0.9%NS. The affected product is identified by Rx # 29082 and has a discard date of 05/19/14. The recall covers all lots of sterile products compounded by the pharmacy within their expiry dates.
The recall was initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Specifically, the agency cited a lack of assurance of sterility for the compounded products. The agency has classified this recall as Class II.
The affected units were distributed in Florida. Patients who have received this medication should contact their healthcare provider for further instructions on whether to discontinue use or obtain a replacement.
The recalled product
- Product
- Unasyn (ampicillin/sulbactam) 1.5 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29082, Discard After 05/19/14
- Manufacturer
- Franck's Lab Inc dba Trinity Care Solutions
- Category
- Drug — Antibiotic
- Affected units
- 60
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 (1)
- Rx # 29082 Exp. 5/19/14
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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