Class II · Moderate risk
Albuterol Sulfate Inhalation Solution
Labelling: Illegible label
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
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
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC 0487-0201-03) and b) 60 count (NDC 0487-0201-60) vials per carton, Rx only, Nephron Pharmaceutical Corporation, Orlando, FL
Affected NDCs
0487-0201-03
0487-0201-60
Compare with the code on your package — it is the most precise check available.
Drug: Albuterol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Ipratropium Bromide and Albuterol Sulfate NDC 00487-0201 |
IPRATROPIUM BROMIDE .5 mg/3mL; ALBUTEROL SULFATE 3 mg/3mL | Solution Respiratory (inhalation) |
Nephron Pharmaceuticals Corporation | Rx |
- Recalling firm
- Nephron Pharmaceuticals Corp.
- NDC code
- 0487-0201-03
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0010-2016 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Albuterol recalls
See all
Class III · Low risk
Albuterol Sulfate
Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Class II · Moderate risk
Airsupra (albuterol and budesonide)
Defective delivery system
Class II · Moderate risk
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Class I · High risk
Albuterol Sulfate Inhalation Aerosol
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Other recalls by Nephron Pharmaceuticals Corp.
All 2015 recalls
Class III · Low risk
PF-Succinylcholine Chloride Injection
Incorrect labeling: Incorrect or missing lot and/or exp date
Class II · Moderate risk
del Nido Cardioplegia Solution
Lack of Assurance of Sterility; bags have potential to leak
Class II · Moderate risk
Amino Acid Injection 50 g/1000 mL
Lack of Assurance of Sterility; bags have potential to leak
Class II · Moderate risk
PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9%…
GMP Deviations: potential glass contamination
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