CLASS IIONGOINGDrug recall · Reported 30 Jul 2014 · FDA Enforcement Report
Unasyn (ampicillin/sulbactam) 1.5 gm/ 0.9%NS recalled by Franck's Lab
Franck's Lab is recalling Unasyn (ampicillin/sulbactam) 1.5 gm/ 0.9%NS, Trinity Care Solutions, 202-C SW 17th, 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 # 29082 Exp. 5/19/14
Quantity recalled60 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.
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
Unasyn (ampicillin/sulbactam) 1.5 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29082, Discard After 05/19/14
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 # 29082 Exp. 5/19/14
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.