Recalls / Class II
Class IID-1878-2019
Product
Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30
- Affected lot / code info
- Lot #: 9B21A, Exp. 1/2022
Why it was recalled
cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the product, but rather were identified on the filling line.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 10,543 tubes
- Distribution pattern
- Nationwide within the United States and Puerto Rico
Timeline
- Recall initiated
- 2019-09-17
- FDA classified
- 2019-09-24
- Posted by FDA
- 2019-10-02
- Terminated
- 2022-08-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1878-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.