Agency classClass IIOur severity:Severe FDA (Drugs)·D-1476-2014·Announced 2014-07-30

Trinity Care Solutions Recalls Compounded Cubicin Due to Sterility Concerns

Trinity Care Solutions is recalling compounded Cubicin 543 mg/100 mL due to quality control concerns regarding sterility assurance 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in parenteral products, 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 10 units of compounded Cubicin 543 mg/100 mL 0.9%NS. The affected products are identified by prescription numbers 29175 (discard after 05/21/14) and 28830 (discard after 05/17/14). The recall is limited to products distributed in Florida.

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. All lots of sterile products compounded by the pharmacy within their expiry dates are subject to this recall.

This is an FDA Class II recall. Patients who have received these specific compounded prescriptions should contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product: Cubicin 543 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29175, Discard After 05/21/14; Rx # 28830, Discard After 05/17/14
Manufacturer: Franck's Lab Inc dba Trinity Care Solutions
Category: Drug — Compounded Sterile Preparations
Hazard: sterility
infection
Affected units: 10

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 (4)

Rx # 29175
Exp 05/21/14
Rx # 28830
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

See all →

Severe
Trinity Care Solutions Recalls ANA Kit Due to Sterility Concerns
FDA (Drugs) · 2014-07-30
Severe
Trinity Care Solutions Recalls Compounded Cubicin Due to Sterility Concerns
FDA (Drugs) · 2014-07-30
Severe
Trinity Care Solutions Recalls Desferal Sterile Compounds Due to Sterility Concerns
FDA (Drugs) · 2014-07-30
Severe
Trinity Care Solutions Recalls Compounded Cubicin Due to Sterility Concerns
FDA (Drugs) · 2014-07-30
Severe
Trinity Care Solutions Recalls Unasyn Due to Sterility Concerns
FDA (Drugs) · 2014-07-30

Same hazard · sterility