Why it was recalled
Presence of Particulate Matter: particulate matter identified as glass in one vial.
Product description
Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03
Lot numbers, UPCs & expiration codes
Lot #: 4750915, Exp 9/2017
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-0859-2016
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 9, 2016
- FDA report date
- Jun 1, 2016
- Quantity
- 6,291 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0859-2016, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 73455
- Address
- 1090 Horsham Rd
- Code information
- Lot #: 4750915, Exp 9/2017
- Postal code
- 19454-1505
- Report date
- Jun 1, 2016
- Product type
- Drugs
- Recall number
- D-0859-2016
- Classification
- Class I
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 6,291 units
- Termination date
- Feb 7, 2017
- Reason for recall
- Presence of Particulate Matter: particulate matter identified as glass in one vial.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Mar 9, 2016
- Initial firm notification
- Letter
- Center classification date
- May 23, 2016