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TETRACAINE HYDROCHLORIDE Recall D-0741-2022

Description: TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufactured for Cameron Pharmaceuticals, LLC., NDC 42494-437-10.

TETRACAINE HYDROCHLORIDE Recall D-0741-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0741-2022
Event ID89803
BrandTETRACAINE
Generic NameTETRACAINE HYDROCHLORIDE
ManufacturerTETRACAINE HYDROCHLORIDE
Original Package?1
Active SubstanceTETRACAINE HYDROCHLORIDE
Drug RouteORAL
DistributionNationwide in the U.S.A
Quantity722 boxes
Recall ReasonLack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Drug ClassificationClass II
Drug Code Info20220413
Product NDC42494-437
Recall Initiation Date20220314
Report Date20220413
Classification Date20220405
Address3030 Bunker Hill St Ste 203
San Diego, CA 92109-5754
United States
Recalling FirmVitae Enim Vitae Scientific, Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Unique Ingredient Identifier5NF5D4OPCI
Structured Product Labeling (SPL ID)c513e659-6c72-43d2-b46c-27cf9a0e3f79
Structured Product Labeling (SPL Set ID)80a96844-f983-4852-8197-a46a5f60461d
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