Recalls / Class I
Class ID-0859-2016
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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
- Affected lot / code info
- Lot #: 4750915, Exp 9/2017
Why it was recalled
Presence of Particulate Matter: particulate matter identified as glass in one vial.
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
- 6,291 units
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-03-09
- FDA classified
- 2016-05-23
- Posted by FDA
- 2016-06-01
- Terminated
- 2017-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0859-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.