CLASS II Drug recall · Reported 5 Nov 2014 · FDA Enforcement Report
Vancomycin 25 mg/mL opthalmic solution recalled
Martin Avenue Pharmacy is recalling Vancomycin 25 mg/mL opthalmic solution, distributed nationwide in the US. The recall was initiated on 27 Aug 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-0168-2015
- FDA event ID
- 69152
- Recalling firm
- Martin Avenue Pharmacy, Naperville, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Aug 2014
- FDA classified
- 29 Oct 2014
- Reported
- 5 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Antibiotics
Timeline
| 27 Aug 2014 | Recall initiated by company | |
| 29 Oct 2014 | Classified by FDA | +63 days |
| 5 Nov 2014 | 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: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
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 an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Where it was distributed
Nationwide
Questions about this recall
Is Vancomycin 25 mg/mL opthalmic solution recalled?
Yes. Martin Avenue Pharmacy recalled Vancomycin 25 mg/mL opthalmic solution on 27 Aug 2014. The recall is Class II and its status is Terminated. Recall number D-0168-2015.
Why was it recalled?
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Which lots are affected?
Lot Number: 06102014@40, Exp 9/8/2014
Where was it sold?
Nationwide
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.
More recalls from Martin Avenue Pharmacy
All 118| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dihydroergotamine mesylate 1 mg/mL injection solution recalled | Martin Avenue Pharmacy | Foreign Material | Nationwide |
| Drug | CLASS II | Nalbuphine 10 mg/mL injection solution recalled | Martin Avenue Pharmacy | Foreign Material | Nationwide |
| Drug | CLASS II | Fentanyl/bupivacaine 3000 mcg/30 mg/mL injectable recalled | Martin Avenue Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Tri-mix, 15 mg/0.5 mg/10 mcg/mL (papaverine recalled | Martin Avenue Pharmacy | Foreign Material | Nationwide |
| Drug | CLASS II | Bacteriostatic water for injection recalled by Martin Avenue Pharmacy | Martin Avenue Pharmacy | Foreign Material | Nationwide |