Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg recall: Sterility Concern
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
Why was Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg recalled?
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a) Lot D4E20A, exp 3/2016 and b) Lot D4C21A, exp 3/2016
- Product
- 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
- Recalling firm
- Nephron Pharmaceuticals Corp.
- Quantity
- a) 85,248 cartons and b) 35,292 cartons
- Distribution
- Nationwide
- Recall date
- October 21, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)