CLASS II ONGOING Drug recall · Reported 30 Jul 2014 · FDA Enforcement Report
Cubicin 543 mg/ 0.9%NS, Trinity Care Solutions recalled by Franck's Lab
Franck's Lab is recalling Cubicin 543 mg/ 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL, distributed in Florida. The recall was initiated on 15 May 2014 and the FDA has classified it as Class II.
Check your package
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-1476-2014
- 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 2014 | Recall initiated by company | |
| 24 Jul 2014 | Classified by FDA | +70 days |
| 30 Jul 2014 | Published 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
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
Where it was distributed
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 # 29175, Exp 05/21/14; Rx # 28830, Exp 05/17/14
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 68497This 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.
More recalls from Franck's Lab
All 30Other Cubicin recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cubicin 700 mg/ 0.9%NS, Trinity Care Solutions recalled by Franck's Lab | Franck's Lab | Sterility | FL |
| Drug | CLASS II | Cubicin 444 mg/ 0.9%NS, Trinity Care Solutions recalled by Franck's Lab | Franck's Lab | Sterility | FL |
| Drug | CLASS II | Cubicin 600 mg/ 0.9%NS, Trinity Care Solutions recalled by Franck's Lab | Franck's Lab | Sterility | FL |
| Drug | CLASS II | Cubicin 486 mg/ 0.9%NS, Trinity Care Solutions recalled by Franck's Lab | Franck's Lab | Sterility | FL |