Why it was recalled
Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and Color of Solution.
Product description
Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA. NDC: 67457-187-50
Lot numbers, UPCs & expiration codes
Lot #: Lot N1700771, EXP October 2020; Lot N1800127, EXP February 2021
Where it was sold
Distributed Nationwide in the USA
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-1271-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 5, 2020
- FDA report date
- May 27, 2020
- Quantity
- 3,010 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Institutional LLC
Original FDA data
Every field from FDA enforcement report D-1271-2020, exactly as published.
Show all FDA fields
- City
- Rockford
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 85624
- Address
- 4901 Hiawatha Dr
- Code information
- Lot #: Lot N1700771, EXP October 2020; Lot N1800127, EXP February 2021
- Postal code
- 61103-1287
- Report date
- May 27, 2020
- Product type
- Drugs
- Recall number
- D-1271-2020
- Classification
- Class II
- Recalling firm
- Mylan Institutional LLC
- Product quantity
- 3,010 vials
- Termination date
- Jan 26, 2022
- Reason for recall
- Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and Color of Solution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA. NDC: 67457-187-50
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- May 5, 2020
- Initial firm notification
- Letter
- Center classification date
- May 20, 2020