FDA Recall D-0211-2017
Guardian Pharmacy Services · Dallas, TX
Class I — life-threatening Terminated 318 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only
Reason for recall
Non-Sterility: failed sterility test result.
Recall record
- Recall number
D-0211-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- Two medical facilities in TX
- Recall initiated
- 2016-09-23
- Classified by FDA Center
- 2016-12-22
- FDA published
- 2016-12-28
- Terminated
- 2017-08-07
- Recalling firm
- Guardian Pharmacy Services
- Firm location
- Dallas, TX