LIDOCAINE HYDROCHLORIDE Recall D-0296-2022
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-0296-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0296-2022 |
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 | 7,176 bottles |
Recall Reason | Superpotent Drug: Minimally superpotent |
Drug Classification | Class II |
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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