Recalls / Class II
Class IID-0279-2022
Product
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent Pharma Inc., Buena, NJ 06310, Distributed by: McKesson Corporation dba Sky Packaging, 497 Southridge Blvd, Suite 101, Memphis, TN 36141, NDC 63739-997-64.
- Brand name
- Lidocaine Hydrochloride
- Generic name
- Lidocaine Hydrochloride
- Active ingredient
- Lidocaine Hydrochloride
- Route
- Topical
- NDC
- 63739-997
- FDA application
- ANDA204494
- Affected lot / code info
- Lot #: 16306, Exp. Date 01/2024.
Why it was 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.
Recalling firm
- Firm
- Teligent Pharma, Inc.
- Manufacturer
- McKesson Corporation dba SKY Packaging
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 105 Lincoln Avenue, Buena, New Jersey 08310
Distribution
- Quantity
- 7,008 glass bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-10-12
- FDA classified
- 2021-12-13
- Posted by FDA
- 2021-12-22
- Terminated
- 2024-06-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0279-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.