LIDOCAINE HYDROCHLORIDE Recall D-0295-2022
Description: 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
LIDOCAINE HYDROCHLORIDE Recall D-0295-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0295-2022 |
| Event ID | 89135 |
| Brand | LIDOCAINE HYDROCHLORIDE |
| Generic Name | LIDOCAINE HYDROCHLORIDE |
| Manufacturer | LIDOCAINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | LIDOCAINE HYDROCHLORIDE |
| Drug Route | TOPICAL |
| Distribution | Distributed to a wholesaler in CO who further distributed Nationwide in the USA |
| Quantity | 6,816 bottles |
| Recall Reason | Superpotent Drug |
| Drug Classification | Class I |
| Drug Code Info | 20220105 |
| Product NDC | 63739-997 |
| Recall Initiation Date | 20211130 |
| Report Date | 20220105 |
| Classification Date | 20211228 |
| Address | 105 Lincoln Avenue Buena, NJ 08310 United States |
| Recalling Firm | Teligent Pharma, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | V13007Z41A |
| Drug Application Number | ANDA204494 |
| Structured Product Labeling (SPL ID) | 98d72406-443b-4615-be83-7106068511d9 |
| Structured Product Labeling (SPL Set ID) | 903cd7bd-6c3d-4068-bb24-e91b1ca1393d |
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