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PAPAVERINE HYDROCHLORIDE Recall D-0742-2022

Description: PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 72516-024-25) and b) 10 x 2mL Single Use Vials per box (NDC 72516-024-10); Manufactured for Oryza Pharmaceuticals, Inc.

PAPAVERINE HYDROCHLORIDE Recall D-0742-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0742-2022
Event ID89803
BrandPAPAVERINE HYDROCHLORIDE
Generic NamePAPAVERINE HYDROCHLORIDE
ManufacturerPAPAVERINE HYDROCHLORIDE
Original Package?1
Active SubstancePAPAVERINE HYDROCHLORIDE
Drug RouteINTRAVENOUS
DistributionNationwide in the U.S.A
Quantitya) 2,098 boxes; b) 700 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 NDC72516-024
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 Identifier23473EC6BQ
Structured Product Labeling (SPL ID)160e9fb1-4feb-45d6-84d7-14244a9501cf
Structured Product Labeling (SPL Set ID)5ba6e650-a5b5-4381-a62a-b7a6df73e8e6
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