CLASS II Drug recall · Reported 15 Aug 2018 · FDA Enforcement Report
EDTA Disodium 30 mg/mL PF recalled by Guardian Pharmacy Services
Guardian Pharmacy Services is recalling EDTA Disodium 30 mg/mL PF, distributed in Texas. The recall was initiated on 17 May 2018 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-1055-2018
- FDA event ID
- 80118
- Recalling firm
- Guardian Pharmacy Services, Dallas, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 May 2018
- FDA classified
- 8 Aug 2018
- Reported
- 15 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Compounded Drugs
Timeline
| 17 May 2018 | Recall initiated by company | |
| 8 Aug 2018 | Classified by FDA | +83 days |
| 15 Aug 2018 | 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 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
EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled syringe. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Where it was distributed
Texas
Questions about this recall
Why was it recalled?
Lack of sterility assurance.
Which lots are affected?
Lot: 58897:42 Use By: 07/04/2018
Where was it sold?
Texas
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
22 other products · FDA event 80118This product is part of a recall event; the main page for the event is Methylene Blue 10 mg/mL recalled by Guardian Pharmacy Services.
More recalls from Guardian Pharmacy Services
All 24Other Edta Disodium recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Edta Disodium 15% (150MG/ML) Vials, Medaus Pharmacy recalled | Medaus | Sterility | Nationwide |
| Drug | CLASS II | EDTA Calcium Disodium Injectable, 300mg/mL vial recalled by Downing Labs | Downing Labs | Sterility | Nationwide |
| Drug | CLASS II | EDTA Disodium Injectable, 150mg/mL vial recalled by Downing Labs | Downing Labs | Sterility | Nationwide |
| Drug | CLASS II | EDTA disodium 150 mg/mL Sterile Injection Multi Dose Vial recalled | Pharmacy Creations | Sterility | NJ |
| Drug | CLASS II | Edta Disodium Solution 33.6mg/ML (0.1 Molar) Ophthalmic recalled | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Sterility | Nationwide |