Trinity Care Solutions Recalls Nafcillin Due to Sterility Concerns
Trinity Care Solutions is recalling Nafcillin 12 gm/300 mL units 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 source text identifies the recall as FDA Class II. According to the severity rubric, an FDA Class II recall involving a sterile product with sterility assurance concerns falls under the 'Severe' category (Score 4), as it implies a risk of adverse health consequences.
Plain-English summary
Trinity Care Solutions, operating as Franck's Lab Inc, is recalling five units of Nafcillin 12 gm/300 mL (Rx # 29162, Exp. 5/21/2014). The product was distributed in Florida.
The recall was initiated because of concerns associated with quality control procedures observed during a recent FDA inspection. Specifically, there is a lack of assurance of sterility for the affected sterile products compounded by the pharmacy within their expiry dates.
Patients who have received this medication should contact their healthcare provider for further instructions. 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
- Nafcillin 12 gm/300 mL, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29162, Discard After 05/21/14
- Manufacturer
- Franck's Lab Inc dba Trinity Care Solutions
- Category
- Drug — Antibiotic
- Affected units
- 5
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 29162 Exp. 5/21/2014
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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