Recalls / Class II
Class IID-0296-2022
Product
Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, 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 #: 15594, Exp Date 05/2023
Why it was recalled
Superpotent Drug: Minimally superpotent
Recalling firm
- Firm
- Teligent Pharma, Inc.
- Manufacturer
- McKesson Corporation dba SKY Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 105 Lincoln Avenue, Buena, New Jersey 08310
Distribution
- Quantity
- 7,176 bottles
- Distribution pattern
- Distributed to a wholesaler in CO who further distributed Nationwide in the USA
Timeline
- Recall initiated
- 2021-11-30
- FDA classified
- 2021-12-28
- Posted by FDA
- 2022-01-05
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0296-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.