Why it was recalled
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Product description
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
Lot numbers, UPCs & expiration codes
a) Lot D4E20A, exp 3/2016 and b) Lot D4C21A, exp 3/2016
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0010-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 21, 2015
- FDA report date
- Oct 21, 2015
- Quantity
- a) 85,248 cartons and b) 35,292 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nephron Pharmaceuticals Corp.
Original FDA data
Every field from FDA enforcement report D-0010-2016, exactly as published.
Show all FDA fields
- City
- Orlando
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 72099
- Address
- 4121 SW 34th St
- Code information
- a) Lot D4E20A, exp 3/2016 and b) Lot D4C21A, exp 3/2016
- Postal code
- 32811-6475
- Report date
- Oct 21, 2015
- Product type
- Drugs
- Recall number
- D-0010-2016
- Classification
- Class II
- Recalling firm
- Nephron Pharmaceuticals Corp.
- Product quantity
- a) 85,248 cartons and b) 35,292 cartons
- Termination date
- Feb 10, 2017
- Reason for recall
- Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 21, 2015
- Initial firm notification
- Center classification date
- Oct 9, 2015