CLASS II ONGOING Drug recall · Reported 30 Jul 2014 · FDA Enforcement Report

Nafcillin 12 gm/, Trinity Care Solutions recalled by Franck's Lab

Franck's Lab is recalling Nafcillin 12 gm/, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For, distributed in Florida. The recall was initiated on 15 May 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesRx 29162 Exp. 5/21/2014
Quantity recalled5 units

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-1462-2014
FDA event ID
68497
Recalling firm
Franck's Lab, Ocala, FL
Classification
Class II
Status
Ongoing
Recall initiated
15 May 2014
FDA classified
24 Jul 2014
Reported
30 Jul 2014
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Sterility

Timeline

15 May 2014Recall initiated by company
24 Jul 2014Classified by FDA+70 days
30 Jul 2014Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Florida

Florida

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

Which lots are affected?

Rx 29162 Exp. 5/21/2014

Where was it sold?

Florida

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

29 other products · FDA event 68497

This product is part of a recall event; the main page for the event is Pfizerpen (penicillin G) 24 MU/ 0.9%NS recalled by Franck's Lab.

ReportedClassRecallCompanyReasonWhere
CLASS IIPfizerpen (penicillin G) 24 MU/ 0.9%NS recalled by Franck's LabFranck's LabSterilityFL
CLASS IIAmbisome 285 mg/ D5W, Trinity Care Solutions recalled by Franck's LabFranck's LabSterilityFL
CLASS IICefepime 1 gm/ 0.9%NS, Trinity Care Solutions recalled by Franck's LabFranck's LabSterilityFL
CLASS IIVancomycin 1.25 gm/ 0.9%NS,Trinity Care Solutions recalledFranck's LabSterilityFL
CLASS IIVancomycin 750 mg/ D5W,Trinity Care Solutions recalled by Franck's LabFranck's LabSterilityFL
CLASS IICeftriaxone 2 gm/ 0.9%NS, Trinity Care Solutions recalledFranck's LabSterilityFL
CLASS IICubicin 486 mg/ 0.9%NS, Trinity Care Solutions recalled by Franck's LabFranck's LabSterilityFL
CLASS IIVancomycin 750 mg/ 0.9%NS, Trinity Care Solutions recalledFranck's LabSterilityFL
CLASS IIMeropenem 1 gm/ 0.9%NS, Trinity Care Solutions recalled by Franck's LabFranck's LabSterilityFL
CLASS IICeftriaxone 1 gm/ D5W, Trinity Care Solutions recalled by Franck's LabFranck's LabSterilityFL
CLASS IIANA Kit, Trinity Care Solutions, 202-C SW 17th Street recalledFranck's LabSterilityFL
CLASS IICubicin 600 mg/ 0.9%NS, Trinity Care Solutions recalled by Franck's LabFranck's LabSterilityFL
CLASS IIImpipenem/Cilastin (Primaxin) 500 mg/ 0.9%NS recalled by Franck's LabFranck's LabSterilityFL
CLASS IINormal Saline Syringe, Trinity Care Solutions recalled by Franck's LabFranck's LabSterilityFL
CLASS IIDesferal 2.5 gm/ Sterile Water, Trinity Care Solutions recalledFranck's LabSterilityFL
CLASS IILevofloxacin 750 mg/ D5W, Trinity Care Solutions recalledFranck's LabSterilityFL
CLASS IICubicin 444 mg/ 0.9%NS, Trinity Care Solutions recalled by Franck's LabFranck's LabSterilityFL
CLASS IICubicin 700 mg/ 0.9%NS, Trinity Care Solutions recalled by Franck's LabFranck's LabSterilityFL
CLASS IICefepime 2 gm/ D5W, Trinity Care Solutions recalled by Franck's LabFranck's LabSterilityFL
CLASS IICubicin 543 mg/ 0.9%NS, Trinity Care Solutions recalled by Franck's LabFranck's LabSterilityFL
CLASS IIDesferal 2 gm/ Sterile Water, Trinity Care Solutions recalledFranck's LabSterilityFL
CLASS IIUnasyn (ampicillin/sulbactam) 1.5 gm/ 0.9%NS recalled by Franck's LabFranck's LabSterilityFL
CLASS IIInvanz (ertapenem)1 gm/ 0.9%NS, Trinity Care Solutions recalledFranck's LabSterilityFL
CLASS IITobramycin 300 mg/ Syringe (for Neb) recalled by Franck's LabFranck's LabSterilityFL
CLASS IIVancomycin 1.25 gm/ 0.9%NS, Trinity Care Solutions recalledFranck's LabSterilityFL
CLASS IICefazolin 1 gm/ 0.9%NS, Trinity Care Solutions recalled by Franck's LabFranck's LabSterilityFL
CLASS IIVancomycin 1 gm/ 0.9%NS,Trinity Care Solutions recalled by Franck's LabFranck's LabSterilityFL
CLASS IICefepime 2 gm/ 0.9%NS, Trinity Care Solutions recalled by Franck's LabFranck's LabSterilityFL
CLASS IICeftriaxone 2 gm/ D5W, Trinity Care Solutions recalled by Franck's LabFranck's LabSterilityFL

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