CLASS II Drug recall · Reported 20 Jul 2016 · FDA Enforcement Report
Calcium Sodium Edta 300MG/ML (PF) Vials, Medaus Pharmacy recalled
Medaus is recalling Calcium Sodium Edta 300MG/ML (PF) Vials, Medaus Pharmacy, distributed nationwide in the US. The recall was initiated on 13 May 2016 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-1176-2016
- FDA event ID
- 74466
- Recalling firm
- Medaus, Birmingham, AL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 May 2016
- FDA classified
- 8 Jul 2016
- Reported
- 20 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 13 May 2016 | Recall initiated by company | |
| 8 Jul 2016 | Classified by FDA | +56 days |
| 20 Jul 2016 | 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
Lack of Assurance of Sterility
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
CALCIUM SODIUM EDTA 300MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
Where it was distributed
U.S. Nationwide, Japan, and New Zealand.
Questions about this recall
Is Calcium Sodium Edta 300MG/ML (PF) Vials, Medaus Pharmacy recalled?
Yes. Medaus recalled Calcium Sodium Edta 300MG/ML (PF) Vials, Medaus Pharmacy on 13 May 2016. The recall is Class II and its status is Terminated. Recall number D-1176-2016.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot # : 151123-11, BUD: 05/21/16; Lot #: 160105-24, BUD: 07/03/16; Lot #: 160118-7, BUD: 07/16/16
Where was it sold?
U.S. Nationwide, Japan, and New Zealand.
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 Medaus
All 96| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Manganese Chl 1MG/ML PF Vials, Medaus Pharmacy recalled | Medaus | Sterility | Nationwide |
| Drug | CLASS II | B-complex Nacl 9% (PF) B1-50MG, B2-5-PO4-5MG, B3-50MG recalled by Medaus | Medaus | Sterility | Nationwide |
| Drug | CLASS II | Thiamine 100 MG/ML W/Pres (Benzalkonium 01%) Vials, Medaus Pharmacy recalled | Medaus | Sterility | Nationwide |
| Drug | CLASS II | Estradiolval 3mg/test Cyp 35mg/ Test Prop 35mg/ML W/pres recalled | Medaus | Sterility | Nationwide |
| Drug | CLASS II | Procaine 2% (PF), In a) Vials and b) Vials, Medaus Pharmacy recalled | Medaus | Sterility | Nationwide |