Reported Dec 22, 2021 · Terminated
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent…
Teligent Pharma, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teligent Pharma, Inc. · 105 Lincoln Avenue · Buena, NJ · 08310
Is this the product you have?
- Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only
- Manufactured byTeligent Pharma Inc., Buena, NJ 06310
- Distributed by
McKesson Corporation dba Sky Packaging497 Southridge BlvdSuite 101MemphisTN 36141NDC 63739-997-64
- Lot codes and dates
Lot #: 16306Exp. Date 01/2024
- Amount recalled
- 7,008 glass bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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