FDAFDA · Food and drugs·Recall number D-0281-2022
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50
Published December 22, 2021 · Recall initiated: October 12, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Teligent Pharma, Inc.
- Distributor
- Nationwide within the United States
- Lot
- Lot #: 13058, Exp. date 02/2022 and 13768, Exp. date 05/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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