CLASS II Drug recall · Reported 2 Sep 2015 · FDA Enforcement Report
Vancomycin 25 mg/mL Opthalmic Solution recalled
Liberty Drug & Surgical is recalling Vancomycin 25 mg/mL Opthalmic Solution, distributed in New Jersey, New York. The recall was initiated on 15 Jun 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-1387-2015
- FDA event ID
- 71591
- Recalling firm
- Liberty Drug & Surgical, Chatham, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jun 2015
- FDA classified
- 27 Aug 2015
- Reported
- 2 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Antibiotics
Timeline
| 15 Jun 2015 | Recall initiated by company | |
| 27 Aug 2015 | Classified by FDA | +73 days |
| 2 Sep 2015 | 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: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
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 25 mg/mL Opthalmic Solution, packaged in a) 10 mL bottle and b) 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Where it was distributed
Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Which lots are affected?
Lot #: a) 06042015@15, Exp 06/18/15; 06052015@3, Exp 06/19/15; b) 06082015@21, Exp 06/22/15
Where was it sold?
Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY
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
24 other products · FDA event 71591More recalls from Liberty Drug & Surgical
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Papaverine/Phentolamine/Atropine/PGE-1 Injectable recalled | Liberty Drug & Surgical | Sterility | NJ, NY |
| Drug | CLASS II | Doxycycline/0.9% NaCl 300 mg/ IV recalled by Liberty Drug & Surgical | Liberty Drug & Surgical | Sterility | NJ, NY |
| Drug | CLASS II | Dexamethasone 24 mg/mL Injectable vial recalled | Liberty Drug & Surgical | Sterility | NJ, NY |
| Drug | CLASS II | Tobramycin 14 mg/mL Ophthalmic Solution recalled | Liberty Drug & Surgical | Sterility | NJ, NY |
| Drug | CLASS II | Doxycycline/0.9 % NaCl 100 mg/ IV recalled by Liberty Drug & Surgical | Liberty Drug & Surgical | Sterility | NJ, NY |
Other Vancomycin recalls
All 65| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vancomycin Injection, USP in 5% Dextrose per (5 mg/mL) recalledVancomycin Hydrochloride | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Vancomycin Injection, USP, in 0.9% Sodium Chloride recalledVancomycin Hydrochloride | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg recalledVancomycin Hydrochloride | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Vancomycin 1 MG/ Solution for Intraocular Injection Single Dose Vial recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | vancomycin 750 mg/ added to 0.9% Sodium Chloride, (3 mg/mL), IV recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |