Recalls / Class II
Class IID-0620-2020
Product
Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor, CT 08695 NDC 70004-0723-09
- Affected lot / code info
- 1219012595 29-Dec-19 1219012647 01-Jan-20
Why it was recalled
Presence of Foreign Substance: Foreign material found inside the vial (manufacturer).
Recalling firm
- Firm
- SCA Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 755 Rainbow Rd Ste B, N/A, Windsor, Connecticut 06095-1024
Distribution
- Quantity
- 1363 syringes
- Distribution pattern
- nationwide
Timeline
- Recall initiated
- 2019-11-26
- FDA classified
- 2019-12-10
- Posted by FDA
- 2019-12-18
- Terminated
- 2020-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0620-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.