Recalls / Class I
Class ID-0211-2017
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
Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only
- Affected lot / code info
- Lot #: 50699:00, Exp 10/04/16
Why it was recalled
Non-Sterility: failed sterility test result.
Recalling firm
- Firm
- Guardian Pharmacy Services
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 7920 Elmbrook Dr Ste 108, N/A, Dallas, Texas 75247-4933
Distribution
- Quantity
- 180 syringes
- Distribution pattern
- Two medical facilities in TX
Timeline
- Recall initiated
- 2016-09-23
- FDA classified
- 2016-12-22
- Posted by FDA
- 2016-12-28
- Terminated
- 2017-08-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0211-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.