Class II · Moderate risk
Trimix 30mg/1 mg/10mcg/mL
Lack of Sterility Assurance.
Calcium Gluconate 2.5% a) 250 mL 25 mg/mL NDC 69699-0908-25
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Calcium Gluconate 2.5% a) 250 mL 25 mg/mL NDC 69699-0908-25; b) Nasal Spray 2.5 Inhal Soln. NDC 69699-0908-10; c) Nebulization Solution 2.5% Inhal. Soln NDC 69699-0908-10; d) Nebulization 250 mL 2.5% Inhal Soln NDC 69699-0908-25; e) Oral Spray 2.5% 2.5% Oral Soln NDC 69699-0917-60, Pharm D Solutions, Houston, Texas
Affected NDCs
69699-0908-10
69699-0908-25
69699-0917-60
Compare with the code on your package — it is the most precise check available.
Category: Allergy & Cold Medication
- Recalling firm
- Pharm D Solutions, LLC
- NDC code
- 69699-0908-25
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0149-2019 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Pharm D Solutions, LLC
All 2018 recalls
Class II · Moderate risk
Testosterone Cypionate 200 mg/mL
Lack of Sterility Assurance.
Class II · Moderate risk
Testosterone Cyp/Pro 95/5%
Lack of Sterility Assurance.
Class II · Moderate risk
Testosterone 200 mg/mL
Lack of Sterility Assurance.
Other sterility / contamination recalls from 2018
All sterility / contamination recalls
Class II · Moderate risk
Folic Acid
Lack of sterility assurance.
Class II · Moderate risk
Zinc Sulfate
Lack of sterility assurance.
Class II · Moderate risk
Glycyrrhizic Acid
Lack of sterility assurance.
Class II · Moderate risk
Dexpanthenol
Lack of sterility assurance.
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