Recalls / Class II
Class IID-1200-2016
Product
LIDOCAINE 2% (PF) IN NACL, 10ML Vials, MEDAUS PHARMACY
- Affected lot / code info
- Lot #: 151203-48, BUD: 05/31/16; Lot #: 151204-9, BUD: 06/01/16; Lot #: 151218-20, BUD: 06/15/16; Lot #: 160125-23, BUD: 07/23/16; Lot #: 160125-24, BUD: 07/23/16; Lot #: 160125-25, BUD: 07/23/16; Lot #: 160127-6, BUD: 07/25/16; Lot #: 160302-76, BUD: 08/29/16; Lot #: 160302-77, BUD: 08/29/16
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Medaus, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 6801 Cahaba Valley Rd Ste 116, Birmingham, Alabama 35242-9609
Distribution
- Quantity
- 147 mL in Vials
- Distribution pattern
- U.S. Nationwide, Japan, and New Zealand.
Timeline
- Recall initiated
- 2016-05-13
- FDA classified
- 2016-07-08
- Posted by FDA
- 2016-07-20
- Terminated
- 2017-06-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1200-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.