Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30
Reported: October 2, 2019 Initiated: September 17, 2019 #D-1878-2019
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
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.
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 10,543 tubes
- Distribution
- Nationwide within the United States and Puerto Rico
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30. Recalled by Akorn, Inc.. Units affected: 10,543 tubes.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 2, 2019. Severity: Moderate. Recall number: D-1878-2019.
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