Why it was recalled
Defective Container: Vials may be missing stoppers.
Product description
GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-010-20
Lot numbers, UPCs & expiration codes
Product Code: 1020; NDC: 63323-010-20; Lot Number: 6107992; Expiration Date: 09/2015
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-0290-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 12, 2014
- FDA report date
- Dec 17, 2014
- Quantity
- 92,125 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-0290-2015, exactly as published.
Show all FDA fields
- City
- Melrose Park
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 69810
- Address
- 2045 Cornell Ave
- Code information
- Product Code: 1020; NDC: 63323-010-20; Lot Number: 6107992; Expiration Date: 09/2015
- Postal code
- 60160-1002
- Report date
- Dec 17, 2014
- Product type
- Drugs
- Recall number
- D-0290-2015
- Classification
- Class II
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 92,125 vials
- Termination date
- Mar 8, 2016
- Reason for recall
- Defective Container: Vials may be missing stoppers.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-010-20
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Nov 12, 2014
- Initial firm notification
- Letter
- Center classification date
- Dec 8, 2014