Teligent recalls 50mL Lidocaine Hydrochloride Topical Solution 4% (Rx) due to cracked caps causing superpotent solution. Products manufactured at same facility as those with cracked seals.
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.
Teligent is recalling 50mL glass bottles of Lidocaine Hydrochloride Topical Solution 4% (Rx only) because they were made at the same facility as products that had cracked seals. This could create a superpotent solution that poses a risk of serious injury if used improperly.
The product was manufactured at the same facility as items that had cracked seals. Cracked seals can cause the solution to become superpotent, meaning it may cause serious injury if used incorrectly.
Prescription users of Lidocaine Hydrochloride Topical Solution 4% (50mL glass bottles) manufactured by Teligent. People using this product for pain relief are most at risk.
Check for 50mL glass bottles labeled 'Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL)'. Products were manufactured by Teligent Pharma Inc. in Buena, NJ and distributed by McKesson in Memphis, TN. Lot number 16306 with expiration 01/2024.
Look for the product name, size, and lot number on the bottle label to confirm if it's affected.
The recall states that products with cracked seals were found to be superpotent, so affected products may pose a risk of serious injury if used incorrectly.
The recall does not specify a remedy, so you should check with Teligent or your healthcare provider for guidance.
Check for 50mL glass bottles labeled 'Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL)' with lot number 16306 and expiration 01/2024.
We’ve drafted a message you can send Teligent to request your refund or repair — edit it as you like.
Subject: Recall D-0279-2022 — Teligent Teligent Hello, I own a Teligent that is covered by recall D-0279-2022 from Teligent. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
