Why it was recalled
Lack of Assurance of Sterility
Product description
Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only, Manufactured by: nephron pharmaceuticals corporation, Orlando, FL 32811, NDC 0487-9501-60.
Lot numbers, UPCs & expiration codes
Lot #: A0654A, Exp 07/12; A0A62A, Exp 10/12
Where it was sold
Nationwide and Puerto Rico
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-1446-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 22, 2011
- FDA report date
- Aug 15, 2012
- Quantity
- 56,028 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nephron Pharmaceuticals Corp.
Original FDA data
Every field from FDA enforcement report D-1446-2012, exactly as published.
Show all FDA fields
- City
- Orlando
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 62604
- Address
- 4121 SW 34th St
- Code information
- Lot #: A0654A, Exp 07/12; A0A62A, Exp 10/12
- Postal code
- 32811-6475
- Report date
- Aug 15, 2012
- Product type
- Drugs
- Recall number
- D-1446-2012
- Classification
- Class II
- Recalling firm
- Nephron Pharmaceuticals Corp.
- Product quantity
- 56,028 cartons
- Termination date
- Nov 15, 2012
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only, Manufactured by: nephron pharmaceuticals corporation, Orlando, FL 32811, NDC 0487-9501-60.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jun 22, 2011
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Aug 9, 2012