Class II · Moderate risk
Albuterol Sulfate Inhalation Solution 0.083%
cGMP deviations: Temperature abuse
National Drug Code
Is NDC 0487-9501-03 recalled?
Albuterol Sulfate · 1 POUCH in 1 CARTON (0487-9501-03) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
Yes — this exact package was recalled
1 FDA recall names the code 0487-9501-03 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- Albuterol Sulfate
- Strength
- ALBUTEROL SULFATE 2.5 mg/3mL
- Form
- Solution · Respiratory (inhalation)
- Labeler
- Nephron Pharmaceuticals Corporation
- Type
- Human Prescription Drug
- Product code
- 0487-9501
Recalls naming this package
Class II · Moderate risk
Albuterol Sulfate Inhalation Solution 0.083%
cGMP deviations: Temperature abuse
Class II · Moderate risk
Albuterol Sulfate Inhalation Solution
Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.
Class II · Moderate risk
Albuterol Sulfate Inhalation Solution
Lack of Assurance of Sterility
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.