Recalls / Class II
Class IID-0290-2015
Product
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
- Brand name
- Gentamicin
- Generic name
- Gentamicin Sulfate
- Active ingredient
- Gentamicin Sulfate
- Route
- Intramuscular, Intravenous
- NDC
- 63323-010
- FDA application
- ANDA062366
- Affected lot / code info
- Product Code: 1020; NDC: 63323-010-20; Lot Number: 6107992; Expiration Date: 09/2015
Why it was recalled
Defective Container: Vials may be missing stoppers.
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2045 Cornell Ave, N/A, Melrose Park, Illinois 60160-1002
Distribution
- Quantity
- 92,125 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-11-12
- FDA classified
- 2014-12-08
- Posted by FDA
- 2014-12-17
- Terminated
- 2016-03-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0290-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.