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.
Product description
Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30
Lot numbers, UPCs & expiration codes
Lot #: 9B21A, Exp. 1/2022
Where it was sold
Nationwide within the United States and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1878-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 17, 2019
- FDA report date
- Oct 2, 2019
- Quantity
- 10,543 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-1878-2019, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 83721
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot #: 9B21A, Exp. 1/2022
- Postal code
- 60045-4862
- Report date
- Oct 2, 2019
- Product type
- Drugs
- Recall number
- D-1878-2019
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Product quantity
- 10,543 tubes
- Termination date
- Aug 1, 2022
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30
- Distribution pattern
- Nationwide within the United States and Puerto Rico
- Recall initiation date
- Sep 17, 2019
- Initial firm notification
- Letter
- Center classification date
- Sep 24, 2019