Recalls / Class II
Class IID-0023-2017
Product
Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials).
- Affected lot / code info
- Lot # 7080315, 7400315, 7410315, 7980415
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 27,547 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-07-29
- FDA classified
- 2016-10-12
- Posted by FDA
- 2016-10-19
- Terminated
- 2018-02-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0023-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.