Recalls / Class II
Class IID-0374-2019
Product
0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) 5 mL in 5 mL BD Syringe, 10 per carton Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478.
- Affected lot / code info
- Service Code 2K2466 and 2K2470 183320004S, 183330008S, 183340002S, 183340003S, 183300004S, 183310007S, 183370041S, 183310043S, 183370042S, 183320003S, 183380007S, 183250013S, 183250014S, 183320005S, 183330009S, 183370007S, 183390044S, 183400006S, 183410003S.
Why it was recalled
Subpotent
Recalling firm
- Firm
- PharMEDium Services, LLC.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 913 N Davis Ave, Cleveland, Mississippi 38732-2106
Distribution
- Quantity
- 7,711 syringes
- Distribution pattern
- Product was distributed throughout the United States.
Timeline
- Recall initiated
- 2019-01-02
- FDA classified
- 2019-01-14
- Posted by FDA
- 2019-01-16
- Terminated
- 2020-05-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0374-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.