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
Reported: December 22, 2021 Initiated: October 12, 2021 #D-0281-2022
Product Description
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
Reason for Recall
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.
Details
- Recalling Firm
- Teligent Pharma, Inc.
- Units Affected
- 14,664 glass bottles
- Distribution
- Nationwide within the United States
- Location
- Buena, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Teligent Pharma, Inc.. Units affected: 14,664 glass bottles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 22, 2021. Severity: Moderate. Recall number: D-0281-2022.
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