CLASS II Drug recall · Reported 8 Jul 2015 · FDA Enforcement Report
Vancomycin HCl/Heparin, Vancomycin 50mcg/mL / Heparin recalled
Lincare is recalling Vancomycin HCl/Heparin, Vancomycin 50mcg/mL / Heparin 100u/mL, Qty: 3, distributed in Arkansas. The recall was initiated on 28 May 2015 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-1192-2015
- FDA event ID
- 71415
- Recalling firm
- Lincare, Little Rock, AR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 May 2015
- FDA classified
- 1 Jul 2015
- Reported
- 8 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Blood Thinners
Timeline
| 28 May 2015 | Recall initiated by company | |
| 1 Jul 2015 | Classified by FDA | +34 days |
| 8 Jul 2015 | Published in enforcement report | +7 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: Sterility of product is not assured.
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
Vancomycin HCl/Heparin, Vancomycin 50mcg/mL / Heparin 100u/mL, Qty: 3, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Where it was distributed
United States including: Arkansas
Questions about this recall
Is Vancomycin HCl/Heparin, Vancomycin 50mcg/mL / Heparin 100u/mL, Qty: 3 recalled?
Yes. Lincare recalled Vancomycin HCl/Heparin, Vancomycin 50mcg/mL / Heparin 100u/mL, Qty: 3 on 28 May 2015. The recall is Class II and its status is Terminated. Recall number D-1192-2015.
Why was it recalled?
Lack of Assurance of Sterility: Sterility of product is not assured.
Which lots are affected?
Compounded on 05/27/15, Discard After: 06/10/15
Where was it sold?
United States including: Arkansas
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS II | Fluorouracil 4250mg / D5W, Qty recalled by Lincare | Lincare | Sterility | AR |
| Drug | CLASS II | TPN 3:1, Qty: 2, Base Formula NaCl 9%, Dextrose recalled by Lincare | Lincare | Sterility | AR |
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| Drug | CLASS II | Vancomycin HCL 250mg / NS syringe recalled by Lincare | Lincare | Sterility | AR |
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