CLASS II Drug recall · Reported 9 Oct 2013 · FDA Enforcement Report
Sodium Phosphate Injectable Phosphorus 200mEq/ Sodium recalled
Triangle Compounding is recalling Sodium Phosphate Injectable Phosphorus 200mEq/ Sodium Single Dose Vial, distributed in North Carolina. The recall was initiated on 6 Sep 2013 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-1068-2013
- FDA event ID
- 66297
- Recalling firm
- Triangle Compounding, Cary, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Sep 2013
- FDA classified
- 30 Sep 2013
- Reported
- 9 Oct 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Sep 2013 | Recall initiated by company | |
| 30 Sep 2013 | Classified by FDA | +24 days |
| 9 Oct 2013 | Published in enforcement report | +9 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:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
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
Sodium Phosphate Injectable, 150mM/50mL Phosphorus 200mEq/50mL Sodium, 50 mL Single Dose Vial, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.
Where it was distributed
NC
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Which lots are affected?
Lot #814748-LG14917, Exp 10/31/13
Where was it sold?
NC
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
1 other product · FDA event 66297| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Histamine, 10 ng/mL Injectable, MDV recalled by Triangle Compounding | Triangle Compounding | Sterility | NC |
More recalls from Triangle Compounding
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Histamine, 10 ng/mL Injectable, MDV recalled by Triangle Compounding | Triangle Compounding | Sterility | NC |