Agency classClass IIOur severity:Severe FDA (Drugs)·D-1457-2014·Announced 2014-07-30

Trinity Care Solutions Recalls Cefepime Sterile Compounds Due to Sterility Concerns

Trinity Care Solutions is recalling 24 units of Cefepime 2 gm/100 mL D5W 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 source text explicitly states the agency classification is Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterile products where sterility assurance is compromised.

Plain-English summary

Trinity Care Solutions, operating as Franck's Lab Inc, is recalling 24 units of Cefepime 2 gm/100 mL D5W. The affected product is intended for parenteral use only and was distributed in Florida. The recall covers specific prescription lots: Rx # 28288 (Discard After 02/4/14), Rx # 29176 (Discard After 05/21/14), and Rx # 28829 (Discard After 05/17/14).

The recall was initiated due to a lack of assurance of sterility. This action follows concerns associated with quality control procedures observed during a recent FDA inspection. The source text notes that all lots of sterile products compounded by the pharmacy within their expiry dates are subject to this recall.

Consumers and healthcare providers should stop using the affected Cefepime products and contact their pharmacist or the recalling firm for further instructions. The FDA has classified this recall as Class II.

The recalled product

Product: Cefepime 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28288, Discard After 02/4/14; Rx # 29176, Discard After 05/21/14; Rx # 28829, Discard After 05/17/14
Manufacturer: Franck's Lab Inc dba Trinity Care Solutions
Category: Drug — Sterile Compounded Medication
Hazard: sterility
contamination
Affected units: 24

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 (6)

Rx # 28288
Exp 02/4/14
Rx # 29176
Exp 05/21/14
Rx # 28829
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