CLASS I Drug recall · Reported 31 Dec 2014 · FDA Enforcement Report
Tropi/Cyclo/Phenyl/Tobra/Flurb recalled by Pharmacy Creations
Pharmacy Creations is recalling Tropi/Cyclo/Phenyl/Tobra/Flurb (1/1/10/0.3/0.03)% Sterile Ophthalmic Solution Dropper in a, distributed in Florida, New Jersey, New York, Puerto Rico. The recall was initiated on 5 Sep 2014 and the FDA has classified it as Class I.
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-0308-2015
- FDA event ID
- 69184
- Recalling firm
- Pharmacy Creations, Randolph, NJ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 5 Sep 2014
- FDA classified
- 19 Dec 2014
- Reported
- 31 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 5 Sep 2014 | Recall initiated by company | |
| 19 Dec 2014 | Classified by FDA | +105 days |
| 31 Dec 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
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
Tropi/Cyclo/Phenyl/Tobra/Flurb (1/1/10/0.3/0.03)% Sterile Ophthalmic Solution, 1 mL Dropper in a 3 mL bottle, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
Where it was distributed
Directly to patients and physicians in FL, NJ, NY, and Puerto Rico
Questions about this recall
Why was it recalled?
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Which lots are affected?
Lot #: 05202014@3, Exp 11/16/2014
Where was it sold?
Directly to patients and physicians in FL, NJ, NY, and Puerto Rico
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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
3 other products · FDA event 69184This product is part of a recall event; the main page for the event is Ascorbic Acid 500 mg/mL Sterile Injection Multi-dose Vial recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Ascorbic Acid 500 mg/mL Sterile Injection Multi-dose Vial recalled | Pharmacy Creations | Sterility | 4 states | |
| CLASS I | Glutathione 100mg/mL Sterile Injection Multi Dose Vial recalled | Pharmacy Creations | Sterility | 4 states | |
| CLASS I | Magnesium Chloride 20% (200mg/mL) Sterile Injection Multi-Dose Vial recalled | Pharmacy Creations | Sterility | 4 states |
More recalls from Pharmacy Creations
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Magnesium Chloride 20% (200mg/mL) Sterile Injection Multi-Dose Vial recalled | Pharmacy Creations | Sterility | 4 states |
| Drug | CLASS I | Glutathione 100mg/mL Sterile Injection Multi Dose Vial recalled | Pharmacy Creations | Sterility | 4 states |
| Drug | CLASS I | Ascorbic Acid 500 mg/mL Sterile Injection Multi-dose Vial recalled | Pharmacy Creations | Sterility | 4 states |
| Drug | CLASS I | Ascorbic Acid 500 mg/mL Sterile Injection Multi-dose Vial recalled | Pharmacy Creations | Mold | NJ, NY, PR |
| Drug | CLASS II | EDTA disodium 150 mg/mL Sterile Injection Multi Dose Vial recalled | Pharmacy Creations | Sterility | NJ |