Agency classClass IIOur severity:Severe FDA (Drugs)·D-1480-2014·Announced 2014-07-30

Trinity Care Solutions Recalls Ceftriaxone Due to Sterility Concerns

Trinity Care Solutions is recalling 5 units of Ceftriaxone 2 gm/100 mL D5W due to quality control concerns identified during an FDA inspection.

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 source text explicitly states the agency classification is Class II. According to the rubric, an FDA Class II recall involving a sterile product with a lack of assurance of sterility (a significant injury risk) is classified as Severe (Score 4).

Plain-English summary

Trinity Care Solutions, operating as Franck's Lab Inc, is recalling 5 units of Ceftriaxone 2 gm/100 mL D5W. The product is identified by Rx # 29150 and has a discard date of 05/17/14. The recall is limited to products distributed in Florida.

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 has classified this recall as Class II.

Patients who have received this specific product should contact their healthcare provider for further instructions. The recall covers all lots of sterile products compounded by the pharmacy within their expiry dates.

The recalled product

Product: Ceftriaxone 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29150, Discard After 05/17/14
Manufacturer: Franck's Lab Inc dba Trinity Care Solutions
Category: Drug — Compounded Sterile Product
Hazard: sterility
infection
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 (2)

Rx # 29150
Exp 05/17/14

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.

See all 30 products in this recall →

Same manufacturer · Franck's Lab Inc dba Trinity Care Solutions

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Same hazard · sterility